Women's Health

Historically, the role of genetic testing has been to identify familial cancer syndromes and initiate cascade testing. If a germline pathogenic variant is found in an individual, cascade testing involves genetic counseling and testing of blood relatives, starting with those closest in relation to the proband, to identify other family members at high hereditary cancer risk. Once testing identifies those family members at higher cancer risk, these individuals can be referred for risk-reducing procedures. They can undergo screening tests starting at an earlier age and/or increased frequency to help prevent invasive cancer or diagnose it at an earlier stage.

Genetic testing can also inform prognosis. While women with a BRCA1 or BRCA2 mutation are at higher risk of developing ovarian cancer compared with the baseline population, the presence of a germline BRCA mutation has been shown to confer improved survival compared with no BRCA mutation (BRCA wild type). However, more recent data have shown that when long-term survival was analyzed, the prognostic benefit seen in patients with a germline BRCA mutation was lost. The initial survival advantage seen in this population may be related to increased sensitivity to treatment. There appears to be improved response to platinum therapy, which is the standard of care for upfront treatment, in germline BRCA mutation carriers.

Most recently, genetic testing has been used to guide treatment decisions in gynecologic cancers. In 2014, the first poly ADP-ribose polymerase (PARP) inhibitor, olaparib, received Food and Drug Administration approval for the treatment of recurrent ovarian cancer in the presence of a germline BRCA mutation. Now there are multiple PARP inhibitors that have FDA approval for ovarian cancer treatment, some as frontline treatment.

Previous data indicate that 13%-18% of women with ovarian cancer have a germline BRCA mutation that places them at increased risk of hereditary ovarian cancer.¹ Current guidelines from the American Society of Clinical Oncology, the U.S. Preventive Services Task Force, the National Comprehensive Cancer Network, the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists recommend universal genetic counseling and testing for patients diagnosed with epithelial ovarian cancer. Despite these guidelines, rates of referral for genetic counseling and completion of genetic testing are low.

There has been improvement for both referrals and testing since the publication of the 2014 SGO clinical practice statement on genetic testing for ovarian cancer patients, which recommended that all women, even those without any significant family history, should receive genetic counseling and be offered genetic testing.² When including only studies that collected data after the publication of the 2014 SGO clinical practice statement on genetic testing, a recent systematic review found that 64% of patients were referred for genetic counseling and 63% underwent testing.³

Clinical interventions to target genetic evaluation appear to improve uptake of both counseling and testing. These interventions include using telemedicine to deliver genetic counseling services, mainstreaming (counseling and testing are provided in an oncology clinic by nongenetics specialists), having a genetic counselor within the clinic, and performing reflex testing. With limited numbers of genetic counselors (and even further limited numbers of cancer-specific genetic counselors),⁴ referral for genetic counseling before testing is often challenging and may not be feasible. There is continued need for strategies to help overcome the barrier to accessing genetic counseling.

While the data are limited, there appear to be significant disparities in rates of genetic testing. Genetic counseling and testing were completed by White (43% and 40%) patients more frequently than by either Black (24% and 26%) or Asian (23% and 14%) patients.⁴ Uninsured patients were about half as likely (23% vs. 47%) to complete genetic testing as were those with private insurance.⁴

Genetic testing is an important tool to help identify individuals and families at risk of having hereditary cancer syndromes. This identification allows us to prevent many cancers and identify others while still early stage, significantly decreasing the health care and financial burden on our society and improving outcomes for patients. While we have seen improvement in rates of referral for genetic counseling and testing, we are still falling short. Given the shortage of genetic counselors, it is imperative that we find solutions to ensure continued and improved access to genetic testing for our patients.
 

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Norquist BM et al. JAMA Oncol. 2016;2(4):482-90.

2. SGO Clinical Practice Statement. 2014 Oct 1.

3. Lin J et al. Gynecol Oncol. 2021;162(2):506-16.

4. American Society of Clinical Oncology. J Oncol Pract. 2016 Apr;12(4):339-83.

Historically, the role of genetic testing has been to identify familial cancer syndromes and initiate cascade testing. If a germline pathogenic variant is found in an individual, cascade testing involves genetic counseling and testing of blood relatives, starting with those closest in relation to the proband, to identify other family members at high hereditary cancer risk. Once testing identifies those family members at higher cancer risk, these individuals can be referred for risk-reducing procedures. They can undergo screening tests starting at an earlier age and/or increased frequency to help prevent invasive cancer or diagnose it at an earlier stage.

Genetic testing can also inform prognosis. While women with a BRCA1 or BRCA2 mutation are at higher risk of developing ovarian cancer compared with the baseline population, the presence of a germline BRCA mutation has been shown to confer improved survival compared with no BRCA mutation (BRCA wild type). However, more recent data have shown that when long-term survival was analyzed, the prognostic benefit seen in patients with a germline BRCA mutation was lost. The initial survival advantage seen in this population may be related to increased sensitivity to treatment. There appears to be improved response to platinum therapy, which is the standard of care for upfront treatment, in germline BRCA mutation carriers.

Most recently, genetic testing has been used to guide treatment decisions in gynecologic cancers. In 2014, the first poly ADP-ribose polymerase (PARP) inhibitor, olaparib, received Food and Drug Administration approval for the treatment of recurrent ovarian cancer in the presence of a germline BRCA mutation. Now there are multiple PARP inhibitors that have FDA approval for ovarian cancer treatment, some as frontline treatment.

Previous data indicate that 13%-18% of women with ovarian cancer have a germline BRCA mutation that places them at increased risk of hereditary ovarian cancer.¹ Current guidelines from the American Society of Clinical Oncology, the U.S. Preventive Services Task Force, the National Comprehensive Cancer Network, the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists recommend universal genetic counseling and testing for patients diagnosed with epithelial ovarian cancer. Despite these guidelines, rates of referral for genetic counseling and completion of genetic testing are low.

There has been improvement for both referrals and testing since the publication of the 2014 SGO clinical practice statement on genetic testing for ovarian cancer patients, which recommended that all women, even those without any significant family history, should receive genetic counseling and be offered genetic testing.² When including only studies that collected data after the publication of the 2014 SGO clinical practice statement on genetic testing, a recent systematic review found that 64% of patients were referred for genetic counseling and 63% underwent testing.³

Clinical interventions to target genetic evaluation appear to improve uptake of both counseling and testing. These interventions include using telemedicine to deliver genetic counseling services, mainstreaming (counseling and testing are provided in an oncology clinic by nongenetics specialists), having a genetic counselor within the clinic, and performing reflex testing. With limited numbers of genetic counselors (and even further limited numbers of cancer-specific genetic counselors),⁴ referral for genetic counseling before testing is often challenging and may not be feasible. There is continued need for strategies to help overcome the barrier to accessing genetic counseling.

While the data are limited, there appear to be significant disparities in rates of genetic testing. Genetic counseling and testing were completed by White (43% and 40%) patients more frequently than by either Black (24% and 26%) or Asian (23% and 14%) patients.⁴ Uninsured patients were about half as likely (23% vs. 47%) to complete genetic testing as were those with private insurance.⁴

Genetic testing is an important tool to help identify individuals and families at risk of having hereditary cancer syndromes. This identification allows us to prevent many cancers and identify others while still early stage, significantly decreasing the health care and financial burden on our society and improving outcomes for patients. While we have seen improvement in rates of referral for genetic counseling and testing, we are still falling short. Given the shortage of genetic counselors, it is imperative that we find solutions to ensure continued and improved access to genetic testing for our patients.
 

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Norquist BM et al. JAMA Oncol. 2016;2(4):482-90.

2. SGO Clinical Practice Statement. 2014 Oct 1.

3. Lin J et al. Gynecol Oncol. 2021;162(2):506-16.

4. American Society of Clinical Oncology. J Oncol Pract. 2016 Apr;12(4):339-83.

Historically, the role of genetic testing has been to identify familial cancer syndromes and initiate cascade testing. If a germline pathogenic variant is found in an individual, cascade testing involves genetic counseling and testing of blood relatives, starting with those closest in relation to the proband, to identify other family members at high hereditary cancer risk. Once testing identifies those family members at higher cancer risk, these individuals can be referred for risk-reducing procedures. They can undergo screening tests starting at an earlier age and/or increased frequency to help prevent invasive cancer or diagnose it at an earlier stage.

Genetic testing can also inform prognosis. While women with a BRCA1 or BRCA2 mutation are at higher risk of developing ovarian cancer compared with the baseline population, the presence of a germline BRCA mutation has been shown to confer improved survival compared with no BRCA mutation (BRCA wild type). However, more recent data have shown that when long-term survival was analyzed, the prognostic benefit seen in patients with a germline BRCA mutation was lost. The initial survival advantage seen in this population may be related to increased sensitivity to treatment. There appears to be improved response to platinum therapy, which is the standard of care for upfront treatment, in germline BRCA mutation carriers.

Most recently, genetic testing has been used to guide treatment decisions in gynecologic cancers. In 2014, the first poly ADP-ribose polymerase (PARP) inhibitor, olaparib, received Food and Drug Administration approval for the treatment of recurrent ovarian cancer in the presence of a germline BRCA mutation. Now there are multiple PARP inhibitors that have FDA approval for ovarian cancer treatment, some as frontline treatment.

Previous data indicate that 13%-18% of women with ovarian cancer have a germline BRCA mutation that places them at increased risk of hereditary ovarian cancer.¹ Current guidelines from the American Society of Clinical Oncology, the U.S. Preventive Services Task Force, the National Comprehensive Cancer Network, the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists recommend universal genetic counseling and testing for patients diagnosed with epithelial ovarian cancer. Despite these guidelines, rates of referral for genetic counseling and completion of genetic testing are low.

There has been improvement for both referrals and testing since the publication of the 2014 SGO clinical practice statement on genetic testing for ovarian cancer patients, which recommended that all women, even those without any significant family history, should receive genetic counseling and be offered genetic testing.² When including only studies that collected data after the publication of the 2014 SGO clinical practice statement on genetic testing, a recent systematic review found that 64% of patients were referred for genetic counseling and 63% underwent testing.³

Clinical interventions to target genetic evaluation appear to improve uptake of both counseling and testing. These interventions include using telemedicine to deliver genetic counseling services, mainstreaming (counseling and testing are provided in an oncology clinic by nongenetics specialists), having a genetic counselor within the clinic, and performing reflex testing. With limited numbers of genetic counselors (and even further limited numbers of cancer-specific genetic counselors),⁴ referral for genetic counseling before testing is often challenging and may not be feasible. There is continued need for strategies to help overcome the barrier to accessing genetic counseling.

While the data are limited, there appear to be significant disparities in rates of genetic testing. Genetic counseling and testing were completed by White (43% and 40%) patients more frequently than by either Black (24% and 26%) or Asian (23% and 14%) patients.⁴ Uninsured patients were about half as likely (23% vs. 47%) to complete genetic testing as were those with private insurance.⁴

Genetic testing is an important tool to help identify individuals and families at risk of having hereditary cancer syndromes. This identification allows us to prevent many cancers and identify others while still early stage, significantly decreasing the health care and financial burden on our society and improving outcomes for patients. While we have seen improvement in rates of referral for genetic counseling and testing, we are still falling short. Given the shortage of genetic counselors, it is imperative that we find solutions to ensure continued and improved access to genetic testing for our patients.
 

Dr. Tucker is assistant professor of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Norquist BM et al. JAMA Oncol. 2016;2(4):482-90.

2. SGO Clinical Practice Statement. 2014 Oct 1.

3. Lin J et al. Gynecol Oncol. 2021;162(2):506-16.

4. American Society of Clinical Oncology. J Oncol Pract. 2016 Apr;12(4):339-83.

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

The drug fezolinetant, a selective neurokinin-3 receptor antagonist under investigation for treatment of menopausal vasomotor symptoms, showed acceptable long-term safety and tolerability during a 1-year phase 3 randomized controlled trial, according to data presented at the annual meeting of the North American Menopause Society. The study, called SKYLIGHT 4, examined fezolinetant treatment, especially in terms of endometrial health.

The findings mean that fezolinetant “may help bridge a gap in the management of vasomotor symptoms,” according to lead author Genevieve Neal-Perry, MD, PhD, chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

This study was an important step in fezolinetant’s path toward potential approval by the Food and Drug Administration for vasomotor symptoms.

”Moderate and severe vasomotor symptoms can adversely affect quality of life of those affected and result in sleep disruption as well as increased risk for heart disease and other high-risk medical problems,” Dr. Neal-Perry said. “Although menopausal hormone therapy significantly improves vasomotor symptoms, it may not be desired or it may not be safe for some women,” resulting in gaps in care and a need for targeted, nonhormonal therapies for hot flashes. A planned study will also assess the safety of the drug in patients with a diagnosis of hormone-sensitive cancer and disorders that increase the risk for blood clots.

”Fezolinetant has a low side effect profile, it is a nonhormonal option, and it is selective for the neurons that trigger and mediate hot flashes,” Dr. Neal-Perry said.

Hot flashes are caused by kisspeptin, neurokinin B, and dynorphin neurons located in the hypothalamus. Fezolinetant works by selectively blocking the neurokinin 3 receptor (NK3R), which regulates a person’s sense of temperature, Dr. Neal-Perry explained. Overactivation of NK3R, resulting from low estrogen levels, plays a role in the hot flashes and cold sweats women experience during menopause.

Drug development for hot flashes ”has been hampered by a lack of knowledge regarding the biological cause,” Dr. Neal-Perry said. “Now that we have a robust understanding of the basic biology of hot flashes, we can develop novel, highly effective, and targeted therapy.”

This safety study involved 1,830 women, ages 40-65, who were experiencing menopausal vasomotor symptoms and were randomly assigned to one of three arms for 52 weeks: 45 mg of fezolinetant, 30 mg of fezolinetant, or a placebo once daily.

The primary endpoints included the percentage of women with endometrial hyperplasia, the percentage of women with endometrial cancer, and the frequency and severity of treatment-emergent adverse events (TEAEs). To meet the primary safety endpoint, no more than 1% of participants could have hyperplasia or malignancy, with an upper confidence interval boundary not greater than 4%. Women who met prespecified criteria for their endometrial health to be assessed, underwent endometrial biopsies at baseline and at the end of the study. Three independent pathologists analyzed the tissue without knowledge of which study arm each sample came from. Among the 599 endometrial biopsy samples, 0.5% of the 203 participants taking 45 mg fezolinetant had hyperplasia while none of the women in the other two arms did. Among the 210 women taking 30 mg of fezolinetant, 0.5% had a malignancy; no malignancies occurred in the other two arms.

Overall adverse events were similar across all three arms, including rates of adverse events leading to discontinuation. The most common adverse events were headache and COVID-19. TEAEs related to the drug were 18.1% in the 45-mg arm, 15.4% in the 30-mg arm, and 17.4% in the placebo arm. Serious adverse events were similar across all three arms, and only 0.5% of participants in the 45-mg arm experienced drug-related serious adverse events, compared with none of the women in the 30-mg arm and 0.2% of women in the placebo group.

”The frequency of transaminase elevations was low, and these TEAEs were generally isolated, transient, and resolved on treatment or with discontinuation,” the authors reported.

The next steps for fezolinetant will be to assess its effect on mood and quality of life measures related to vasomotor symptoms, Dr. Neal-Perry said.

Samantha Dunham, MD, a NAMS-certified menopause practitioner and an associate professor of obstetrics and gynecology at New York University, suggested the drug’s safety in the study is encouraging.

”As a medication that treats menopausal symptoms, the study confirmed there are no issues with the endometrium, or lining of the uterus, not that one would expect issues given the mechanism of action,” Dr. Dunham, also codirector of NYU Langone’s Center for Midlife Health and Menopause, said in an interview. Dr. Dunham was not involved in the study.

”Earlier versions of medication in this class have caused liver enzyme elevation.” The trial of this medication showed that there were only transient elevations in liver enzymes, which resolved upon cessation of the medication. Dr. Dunham said. ”If the medicine proves to be safe over long periods of time in different populations, this will be a very significant medication for treating menopausal vasomotor symptoms.”

The research was funded by Astellas Pharma. Dr. Dunham had no disclosures. Dr. Neal-Perry is a scientific advisory board member for Astellas and Ferring Pharmaceuticals, and has received research funding from Merck and Overa.

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

Symptoms of menopause can significantly disrupt a woman’s ability to work, according to a cross-sectional study presented at the annual meeting of the North American Menopause Society.

The study, by researchers at the Mayo Clinic, found that roughly one in eight women said issues stemming from menopause caused them to miss multiple days of work; reduce hours on the job; and even quit, retire, or be laid off.

“We were shocked to see the significant impact of menopause symptoms in the workplace,” Ekta Kapoor, MD, an associate professor of medicine at the Mayo Clinic in Rochester, Minn. said in an interview. “The potential economic impact of untreated menopause symptoms at the workplace is mind-boggling.”

The findings represent an opportunity to improve the treatment of menopause symptoms in working women and “draw attention to the need for creation of workplace policies that include education of employers, managers, and supervisors in order to support midlife women during this universal life stage transition,” Dr. Kapoor added.

Laurie Jeffers, DNP, certified menopause practitioner and codirector of the Center for Midlife Health and Menopause within the department of obstetrics & gynecology at New York University Langone Health, said the findings agree with the results of previous studies from the Netherlands and elsewhere.

“We know that across different studies up to 80% of women during the menopause transition and early post menopause will have high symptom burden, with vasomotor symptoms being the most common,” Dr. Jeffers said. “Psychological symptoms were notably significant in this study, which is also not surprising given that there can be an exacerbation of anxiety or depression during the menopausal transition due to the variability of hormonal activity during this time.”
 

4,400 women surveyed

Dr. Kapoor and colleagues analyzed data from 4,440 currently employed women, ages 45-60, who were enrolled in the Mayo Clinic Registry of Midlife Women and completed an online questionnaire between March and June 2021 about their menopause symptoms and the symptoms’ effects on their work. The participants all receive their primary care at one of four Mayo Clinic sites in Rochester; Scottsdale, Ariz.; Jacksonville, Fla.; and northwest Wisconsin.

The researchers defined an adverse outcome from a menopausal symptom as one that directly caused women to miss a day from work in the past year or, within the past 6 months, to cut back on work hours, to experience a layoff or job termination, or to quit, retire or change jobs.

Most of the respondents were White (95%), married (77%), and had at least a college degree (59%), and their average age was 54. Their overall average Menopause Rating Scale (MRS) score – including somatic, psychological, and urogenital domains – was 23.1, which indicated a severe level of menopause symptoms.

More than one in eight women (13%) reported having at least one adverse outcome because of menopause symptoms, most commonly missing work (11%).

The women reported missing an average 3 days of work because of menopause symptoms. About half as many (6%) reported cutting back on hours at work in the past 6 months. A small percentage reported being laid off in the past 6 months (0.3%), or quitting, retiring, or changing jobs in the past 6 months (1%) because of menopause symptoms.

Menopause symptoms may well be contributing to the gender wage gap, Dr. Kapoor said, in the same way that other factors affect women’s overall earnings, such as taking time off for having or raising a family, being responsible for a large share of housework, and taking on more mentoring or teaching roles that aren’t as highly valued at work.

“Women going through the menopause transition, and those who are postmenopausal, are at important stages of their careers,” Dr. Kapoor said. “They are often seeking, or already in leadership positions. Any impediments at this important stage in their professional lives can prove to be very costly, resulting in missed opportunities for promotion and leadership roles.”

Unsurprisingly, the higher a woman’s MRS score, the more likely she was to report an adverse work outcome, regardless of the symptom. For example, women whose symptom severity ranked in the top 25% overall were 15.6 times more likely to have an adverse work experience than those with the lowest level of symptoms (P < .001). Psychological symptoms had the greatest effect on work. Women whose psychological symptoms ranked in the top 25% in terms of severity were 21 times more likely to have an adverse work effect, compared with those with the lowest level of severity, according to the researchers.

The results echo findings from a recent survey from Carrot Fertility of 1,000 women, ages 40-55, about the effects of menopause on their careers. In that survey, 79% of respondents described working during menopause as more challenging than other common life stages and life experiences, including starting a new job, starting a family or getting a promotion.

Yet 77% of women felt uncomfortable talking with executives about the problem, and 63% didn’t feel comfortable talking to human resources about the issue. More than half (58%) didn’t want to discuss it with their immediate supervisor. Only 8% said their employer has offered significant support for menopause.

“Menopause symptoms continue to be undertreated for a variety of reasons [and] impact multiple aspects of a woman’s life, including her performance in the workplace,” Dr. Kapoor said. “In addition to focusing our attention on adequate treatment of menopause symptoms, we need advocacy for creation of workplace policies that can help women navigate this important and universal stage of their lives.”

Those policies might include education about menopause to increase knowledge and awareness among employers and managers, Dr. Kapoor said. She also noted the need to improve communication with women in discussing appropriate support and work adjustments during menopause.

"There is also evidence that less than 20%-30% of women seek help for their symptoms,” Dr. Jeffers said. “There are a variety of evidence-based hormonal and nonhormonal options available to ease these symptoms, and knowledgeable clinical management of these symptoms can favorably impact this transition. This study is interesting in that the population of women surveyed presumably had access to high-quality health resources and yet still had a high symptom burden.”

Dr. Kapoor cautioned that the data collection occurred in the midst of the COVID-19 pandemic, “which may have heightened the adverse experiences of women at the workplace. On the other hand, many of these women may have been working from home, which may have made their menopause experience more favorable than it would have been had they been working in actual offices,” thereby again underrepresenting the problem.

Dr. Kapoor added that the study population may not be representative since they all received treatment at a tertiary health care center and were almost all White women.

“Perhaps the impact of menopause symptoms in the minority populations and the community is even greater,” Dr. Kapoor said. “Our data might be underrepresenting the extent of the problem.”

The research did not use external funding. Dr. Kapoor has received grant support from Mithra Pharmaceuticals and consulted for Astellas, Mithra Pharmaceuticals, Scynexis, and Womaness. Dr. Jeffers had no disclosures.

*This story was updated on Nov. 28, 2022.

Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

• What are outcomes for laser versus sham studies?
• What are long-term outcomes (beyond 6 months)
• What pretreatment is necessary?
• Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
• What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

• What are outcomes for laser versus sham studies?
• What are long-term outcomes (beyond 6 months)
• What pretreatment is necessary?
• Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
• What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

Despite a lack of evidence and high cost, laser therapy continues to attract many women seeking “vaginal rejuvenation” to help reverse the physical symptoms of menopause.

Recent reviews of the medical literature continue to show that laser treatment appears to be less effective than estrogen at improving vaginal dryness and pain during sex, according to Cheryl B. Iglesia, MD, a professor of ob.gyn. and urology at Georgetown University, Washington.

“Laser for GSM [genitourinary syndrome of menopause] is showing some promise, but patients need to be offered [Food and Drug Administration]–approved treatments prior to considering laser, and users need to know how to do speculum and pelvic exams and understand vulvovaginal anatomy and pathology,” Dr. Iglesia, who directs the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said in an interview, adding that patients should avoid “vaginal rejuvenation” treatments offered at med-spas.

Dr. Iglesia reviewed how these lasers work and then discussed the controversy over their marketing and the evidence for their use at the annual meeting of the North American Menopause Society.

By 3 years after menopause, more than half of women experience atrophy in their vagina resulting from a lack of estrogen. Marked by a thinning of the epithelium, reduced blood supply, and loss of glycogen, vulvovaginal atrophy is to blame for GSM.

Vaginal laser therapy has been a popular option for women for the last decade, despite a lack of evidence supporting its use or approval from regulators.

The FDA has issued broad clearance for laser therapy for incision, ablation, vaporization, and coagulation of body soft tissues, such as dysplasia, vulvar or anal neoplasia, endometriosis, condylomas, and other disorders. However, the agency has not approved the use of laser therapy for vulvovaginal atrophy, GSM, vaginal dryness, or dyspareunia.
 

Evidence regarding vaginal laser therapy

According to Dr. Iglesia, the evidence for vaginal laser therapy is mixed and of generally low quality. A systematic review published in the Journal of Sexual Medicine (2022 Jan 29. doi: 10.1016/j.jsxm.2021.12.010) presented mostly low-quality evidence from 25 studies and found promising data for genitourinary symptoms but not enough to justify its use for genitourinary symptoms just yet. Dr. Iglesia discussed her own small, multisite study of 62 participants, which compared vaginal laser with vaginal estrogen and found no differences between the two for multiple outcomes. (The study would have been larger if not for interruption from an FDA warning for an Investigational Device Exemption.)

A JAMA study from Australia found no difference between laser therapy and sham laser therapy, but the most recent systematic review, from JAMA Network Open, found no significant difference between vaginal laser and vaginal estrogen for vaginal and sexual function symptoms. This review, however, covered only the six existing randomized controlled trials, including Dr. Iglesia’s, which were small and had a follow-up period of only 3-6 months.

“There have only been a few randomized controlled trials comparing laser to vaginal estrogen therapy, and most of those did not include a placebo or sham arm,” Monica Christmas, MD, director of the Center for Women’s Integrated Health at the University of Chicago Medicine, said in an interview. “This is extremely important, as most of the trials that did include a sham arm did not find that laser was better than the sham.” Dr. Christmas was not a part of the presentation but attended it at NAMS.

The bottom line, she said, is that “current evidence is not sufficient to make conclusions on long-term safety or sustainability, nor is there compelling evidence to make claims on equivalence to vaginal estrogen therapy.” Currently, committee opinions from a half-dozen medical societies, including NAMS, oppose using vaginal laser therapy until rigorous, robust trials on long-term safety and efficacy have been conducted. The International Continence Society and International Society for the Study of Vulvovaginal Disease issued a joint statement in 2018 that emphasized that histologic changes from lasers do not necessarily equate with changes in function. The statement noted the lack of evidence for laser treatment of incontinence and prolapse and stated that it should not be used for vulvodynia or lichen sclerosus.

A 2020 statement from NAMS found “insufficient placebo-controlled trials of energy-based therapies, including laser, to draw conclusions of efficacy or safety or to make treatment recommendations.” A slightly more optimistic statement from the American Urogynecologic Society concluded that energy-based devices have shown short-term efficacy for menopause-related vaginal atrophy and dyspareunia, including effects lasting up to 1 year from fractionated laser for treat dyspareunia, but also noted that studies up to that time were small and measure various outcomes.
 

Recommendations on vaginal laser therapy

Given this landscape of uneven and poor-quality evidence, Dr. Iglesia provided several “common sense” recommendations for energy-based therapies, starting with the need for any practitioner to have working knowledge of vulvovaginal anatomy. Contraindications for laser therapy include any malignancy – especially gynecologic – undiagnosed bleeding, active herpes or other infections, radiation, and vaginal mesh, particularly transvaginal mesh. The provider also must discuss the limited data on long-term function and treatment alternatives, including FDA-approved therapies like topical estrogen, dehydroepiandrosterone sulfate (DHEA-S), ospemifene, and moisturizers, Dr. Iglesia said.

Adverse events associated with laser therapy, such as scarring or burning, are rare but do occur, and cost remains an issue, Dr. Iglesia said.

“Vaginal estrogen therapy is well established as a safe and effective treatment option based on high quality evidence,” Dr. Christmas said. “This is not the case for laser therapy. Rare, but serious harms are reported with vaginal laser, including burns, scarring, dyspareunia, pain, and potential irreversible damage.”

Dr. Iglesia also cautioned that clinicians should take extra care with vulnerable populations, particularly cancer patients and others with contraindications for estrogen treatment.

For those in whom vaginal estrogen is contraindicated, Dr. Christmas recommended vaginal moisturizers, lubricants, dilators, and physical therapy for the pelvic floor.

“In patients who fail those nonhormonal approaches, short courses of vaginal estrogen therapy or DHEA-S suppository may be employed with approval from their oncologist,” Dr. Christmas said.

Dr. Iglesia finally reviewed the major research questions that remain with laser therapy:

• What are outcomes for laser versus sham studies?
• What are long-term outcomes (beyond 6 months)
• What pretreatment is necessary?
• Could laser be used as a drug delivery mechanism for estrogen, and could this provide a synergistic effect?
• What is the optimal number and interval for laser treatments?

Dr. Iglesia had no industry disclosures but received honoraria for consulting at UpToDate. Dr. Christmas is a consultant for Materna. The presentation did not rely on any external funding.

Does Instagram make new moms feel inadequate? Yes, suggests a new study that warns images of new mothers on social media may drive body dissatisfaction and feelings of not being good enough. 

Lead researcher Megan Gow, PhD, a National Health and Medical Research Council early career fellow at the University of Sydney Children’s Hospital Westmead Clinical School, says she wanted to find out if Instagram images reflected the actual population of postpartum women. 

“We were concerned images would be idealized, placing postpartum women, who are already a vulnerable group, at increased risk,” she says.  

The findings, published recently in the journal Healthcare, suggest social media may not be the right platform to target health messages to new moms.
 

A vulnerable time

The months after an infant’s birth are a vulnerable time for new moms. Women contend with huge hormone shifts, sleep deprivation, and a major life change – all while caring for a new child.

A 2021 Nestle study found 32% of parents feel isolated, while a 2017 online poll in the United Kingdom found 54% of new moms felt “friendless.” And according to the American Psychological Association, up to one in seven new mothers will face postpartum depression, while 9% will have posttraumatic stress disorder, according to Postpartum Support International. 

The pandemic may have worsened the isolation new mothers feel. A May 2022 study in the Journal of Psychiatric Research found U.S. rates of postpartum depression rose in the first year of the COVID-19 pandemic.

While new motherhood was stressful enough in the analog age, women today must contend with social media, which increases feelings of isolation. A June 2021 study published in Frontiers in Psychology said social media users between the ages of 26 and 35 reported higher rates of loneliness. That’s in line with Dr. Gow’s study, which noted 39% of Instagram’s monthly active users are women between the ages of 18 and 44. And nearly two-thirds of them – 63% – log onto the platform daily.

“The postpartum phase can feel very isolated, and being vocal about the postpartum shifts that all mothers go through helps set expectations and normalize the experience for those of us who are post partum,” says Catie de Montille, 36, a mother of two in Washington, D.C. 
 

Instagram sets the wrong expectations

Instagram sets unreasonable expectations for new mothers, Dr. Gow and her colleagues found in their study. 

She and her fellow researchers analyzed 600 posts that used #postpartumbody, a hashtag that had been posted on Instagram more than 2 million times by October 2022. Other hashtags like #mombod and #postbabybody have been used 1.9 million and 320,000 times, respectively.

Of the 600 posts, 409 (68%) focused on a woman as the central image. The researchers analyzed those 409 posts to find out if they reflected women’s post-childbirth reality.

They found that more than 9 in 10 posts (91%) showed women who appeared to have low body fat (37%) or average body fat (54%). Only 9% showed women who seemed to be overweight. And the researchers also found just 5% of images showed features commonly associated with a postpartum body, like stretch marks or scars from cesarean sections. 

Women need to be aware that “what is posted on Instagram may not be realistic and is not representative of the vast majority of women in the postpartum period,” Dr. Gow says. 

The images also did not portray women as physically strong.

Dr. Gow’s team examined 250 images for signs of muscularity. More than half, 52%, showed few or no defined muscles. That finding came even though more than half of the original 409 images showed women in fitness attire (40%), underwear (8%), or a bathing suit (5%).

According to Emily Fortney, PsyD, a licensed clinical psychologist in Sacramento, Calif., the study shows that health care workers must work harder to set expectations for new moms. 

“This is a deeper issue of how women are overall portrayed in the media and the pressure we face to return to some unrealistic size,” she says. “We need to be encouraging women to not focus on photos, but to focus on the postpartum experience in an all-encompassing way that includes both physical and mental health.”
 

Childbirth as an illness to overcome? 

While retail brands from Nike to Versace have begun to show a wider range of female shapes in advertisements and on the runway, postpartum women seem to be left out of this movement. Dr. Gow and her fellow researchers referred to a 2012 study that examined images in popular Australian magazines and concluded these photos likened the pregnant body to an illness from which women needed to recover. 

The images posted on Instagram indicate that belief is still pervasive. The images of postpartum women in fitness clothes suggest “that women want to be seen to be exercising as a means of breaking the ‘hold’ that pregnancy had on them or ‘repairing’ their postpartum body,” Dr. Gow and her fellow researchers say. 

New Orleans resident Sydney Neal, 32, a mother of two who gave birth to her youngest child in November 2021, said social media helped shape her view of what “recovery” would be like.

While Ms. Neal said some celebrities like Chrissy Teigen, a mother of two, have “kept it very real” on Instagram, she also “saw a lot of women on social media drop [their weight] quickly and post as if they were back to normal much faster than 6 months.”
 

Body-positive tools for new moms 

Dr. Gow is continuing to study this topic. Her team is currently doing a study that will ask women about social media use, how they feel about their bodies, and how their beliefs change after viewing images tagged with #postpartumbody. (Women with children under the age of 2 can access the survey here.) 

Because of the unrealistic images, Dr. Gow and her team said Instagram may not be a good tool for sharing health information with new moms.

But there are other options. 

Ms. de Montille, whose children were born in 2020 and 2022, used apps like Back to You and Expectful, and she follows Karrie Locher, a postpartum and neonatal nurse and certified lactation counselor, on Instagram. She said these tools focus on the mind/body connection, which “is better than focusing on the size of your jeans.” 

Women also should be able to turn to trusted health care professionals.

“Providers can start speaking about the romanticization of pregnancy and motherhood starting in prenatal care, and they can start speaking more about social media use and the pros and cons of use specifically in the perinatal period,” says Dr. Fortney. “This opens the door to a discussion on a wide range of issues that can actually help assess, prevent, and treat perinatal mood and anxiety disorders.”

Ms. Neal, the mother of two in New Orleans, said she wished her doctor had talked to her more about what to expect after giving birth. 

“I don’t really know how to crack the body image nut, but I think starting in a medical setting might be helpful,” she says.

A version of this article first appeared on WebMD.com.

Does Instagram make new moms feel inadequate? Yes, suggests a new study that warns images of new mothers on social media may drive body dissatisfaction and feelings of not being good enough. 

Lead researcher Megan Gow, PhD, a National Health and Medical Research Council early career fellow at the University of Sydney Children’s Hospital Westmead Clinical School, says she wanted to find out if Instagram images reflected the actual population of postpartum women. 

“We were concerned images would be idealized, placing postpartum women, who are already a vulnerable group, at increased risk,” she says.  

The findings, published recently in the journal Healthcare, suggest social media may not be the right platform to target health messages to new moms.
 

A vulnerable time

The months after an infant’s birth are a vulnerable time for new moms. Women contend with huge hormone shifts, sleep deprivation, and a major life change – all while caring for a new child.

A 2021 Nestle study found 32% of parents feel isolated, while a 2017 online poll in the United Kingdom found 54% of new moms felt “friendless.” And according to the American Psychological Association, up to one in seven new mothers will face postpartum depression, while 9% will have posttraumatic stress disorder, according to Postpartum Support International. 

The pandemic may have worsened the isolation new mothers feel. A May 2022 study in the Journal of Psychiatric Research found U.S. rates of postpartum depression rose in the first year of the COVID-19 pandemic.

While new motherhood was stressful enough in the analog age, women today must contend with social media, which increases feelings of isolation. A June 2021 study published in Frontiers in Psychology said social media users between the ages of 26 and 35 reported higher rates of loneliness. That’s in line with Dr. Gow’s study, which noted 39% of Instagram’s monthly active users are women between the ages of 18 and 44. And nearly two-thirds of them – 63% – log onto the platform daily.

“The postpartum phase can feel very isolated, and being vocal about the postpartum shifts that all mothers go through helps set expectations and normalize the experience for those of us who are post partum,” says Catie de Montille, 36, a mother of two in Washington, D.C. 
 

Instagram sets the wrong expectations

Instagram sets unreasonable expectations for new mothers, Dr. Gow and her colleagues found in their study. 

She and her fellow researchers analyzed 600 posts that used #postpartumbody, a hashtag that had been posted on Instagram more than 2 million times by October 2022. Other hashtags like #mombod and #postbabybody have been used 1.9 million and 320,000 times, respectively.

Of the 600 posts, 409 (68%) focused on a woman as the central image. The researchers analyzed those 409 posts to find out if they reflected women’s post-childbirth reality.

They found that more than 9 in 10 posts (91%) showed women who appeared to have low body fat (37%) or average body fat (54%). Only 9% showed women who seemed to be overweight. And the researchers also found just 5% of images showed features commonly associated with a postpartum body, like stretch marks or scars from cesarean sections. 

Women need to be aware that “what is posted on Instagram may not be realistic and is not representative of the vast majority of women in the postpartum period,” Dr. Gow says. 

The images also did not portray women as physically strong.

Dr. Gow’s team examined 250 images for signs of muscularity. More than half, 52%, showed few or no defined muscles. That finding came even though more than half of the original 409 images showed women in fitness attire (40%), underwear (8%), or a bathing suit (5%).

According to Emily Fortney, PsyD, a licensed clinical psychologist in Sacramento, Calif., the study shows that health care workers must work harder to set expectations for new moms. 

“This is a deeper issue of how women are overall portrayed in the media and the pressure we face to return to some unrealistic size,” she says. “We need to be encouraging women to not focus on photos, but to focus on the postpartum experience in an all-encompassing way that includes both physical and mental health.”
 

Childbirth as an illness to overcome? 

While retail brands from Nike to Versace have begun to show a wider range of female shapes in advertisements and on the runway, postpartum women seem to be left out of this movement. Dr. Gow and her fellow researchers referred to a 2012 study that examined images in popular Australian magazines and concluded these photos likened the pregnant body to an illness from which women needed to recover. 

The images posted on Instagram indicate that belief is still pervasive. The images of postpartum women in fitness clothes suggest “that women want to be seen to be exercising as a means of breaking the ‘hold’ that pregnancy had on them or ‘repairing’ their postpartum body,” Dr. Gow and her fellow researchers say. 

New Orleans resident Sydney Neal, 32, a mother of two who gave birth to her youngest child in November 2021, said social media helped shape her view of what “recovery” would be like.

While Ms. Neal said some celebrities like Chrissy Teigen, a mother of two, have “kept it very real” on Instagram, she also “saw a lot of women on social media drop [their weight] quickly and post as if they were back to normal much faster than 6 months.”
 

Body-positive tools for new moms 

Dr. Gow is continuing to study this topic. Her team is currently doing a study that will ask women about social media use, how they feel about their bodies, and how their beliefs change after viewing images tagged with #postpartumbody. (Women with children under the age of 2 can access the survey here.) 

Because of the unrealistic images, Dr. Gow and her team said Instagram may not be a good tool for sharing health information with new moms.

But there are other options. 

Ms. de Montille, whose children were born in 2020 and 2022, used apps like Back to You and Expectful, and she follows Karrie Locher, a postpartum and neonatal nurse and certified lactation counselor, on Instagram. She said these tools focus on the mind/body connection, which “is better than focusing on the size of your jeans.” 

Women also should be able to turn to trusted health care professionals.

“Providers can start speaking about the romanticization of pregnancy and motherhood starting in prenatal care, and they can start speaking more about social media use and the pros and cons of use specifically in the perinatal period,” says Dr. Fortney. “This opens the door to a discussion on a wide range of issues that can actually help assess, prevent, and treat perinatal mood and anxiety disorders.”

Ms. Neal, the mother of two in New Orleans, said she wished her doctor had talked to her more about what to expect after giving birth. 

“I don’t really know how to crack the body image nut, but I think starting in a medical setting might be helpful,” she says.

A version of this article first appeared on WebMD.com.

Does Instagram make new moms feel inadequate? Yes, suggests a new study that warns images of new mothers on social media may drive body dissatisfaction and feelings of not being good enough. 

Lead researcher Megan Gow, PhD, a National Health and Medical Research Council early career fellow at the University of Sydney Children’s Hospital Westmead Clinical School, says she wanted to find out if Instagram images reflected the actual population of postpartum women. 

“We were concerned images would be idealized, placing postpartum women, who are already a vulnerable group, at increased risk,” she says.  

The findings, published recently in the journal Healthcare, suggest social media may not be the right platform to target health messages to new moms.
 

A vulnerable time

The months after an infant’s birth are a vulnerable time for new moms. Women contend with huge hormone shifts, sleep deprivation, and a major life change – all while caring for a new child.

A 2021 Nestle study found 32% of parents feel isolated, while a 2017 online poll in the United Kingdom found 54% of new moms felt “friendless.” And according to the American Psychological Association, up to one in seven new mothers will face postpartum depression, while 9% will have posttraumatic stress disorder, according to Postpartum Support International. 

The pandemic may have worsened the isolation new mothers feel. A May 2022 study in the Journal of Psychiatric Research found U.S. rates of postpartum depression rose in the first year of the COVID-19 pandemic.

While new motherhood was stressful enough in the analog age, women today must contend with social media, which increases feelings of isolation. A June 2021 study published in Frontiers in Psychology said social media users between the ages of 26 and 35 reported higher rates of loneliness. That’s in line with Dr. Gow’s study, which noted 39% of Instagram’s monthly active users are women between the ages of 18 and 44. And nearly two-thirds of them – 63% – log onto the platform daily.

“The postpartum phase can feel very isolated, and being vocal about the postpartum shifts that all mothers go through helps set expectations and normalize the experience for those of us who are post partum,” says Catie de Montille, 36, a mother of two in Washington, D.C. 
 

Instagram sets the wrong expectations

Instagram sets unreasonable expectations for new mothers, Dr. Gow and her colleagues found in their study. 

She and her fellow researchers analyzed 600 posts that used #postpartumbody, a hashtag that had been posted on Instagram more than 2 million times by October 2022. Other hashtags like #mombod and #postbabybody have been used 1.9 million and 320,000 times, respectively.

Of the 600 posts, 409 (68%) focused on a woman as the central image. The researchers analyzed those 409 posts to find out if they reflected women’s post-childbirth reality.

They found that more than 9 in 10 posts (91%) showed women who appeared to have low body fat (37%) or average body fat (54%). Only 9% showed women who seemed to be overweight. And the researchers also found just 5% of images showed features commonly associated with a postpartum body, like stretch marks or scars from cesarean sections. 

Women need to be aware that “what is posted on Instagram may not be realistic and is not representative of the vast majority of women in the postpartum period,” Dr. Gow says. 

The images also did not portray women as physically strong.

Dr. Gow’s team examined 250 images for signs of muscularity. More than half, 52%, showed few or no defined muscles. That finding came even though more than half of the original 409 images showed women in fitness attire (40%), underwear (8%), or a bathing suit (5%).

According to Emily Fortney, PsyD, a licensed clinical psychologist in Sacramento, Calif., the study shows that health care workers must work harder to set expectations for new moms. 

“This is a deeper issue of how women are overall portrayed in the media and the pressure we face to return to some unrealistic size,” she says. “We need to be encouraging women to not focus on photos, but to focus on the postpartum experience in an all-encompassing way that includes both physical and mental health.”
 

Childbirth as an illness to overcome? 

While retail brands from Nike to Versace have begun to show a wider range of female shapes in advertisements and on the runway, postpartum women seem to be left out of this movement. Dr. Gow and her fellow researchers referred to a 2012 study that examined images in popular Australian magazines and concluded these photos likened the pregnant body to an illness from which women needed to recover. 

The images posted on Instagram indicate that belief is still pervasive. The images of postpartum women in fitness clothes suggest “that women want to be seen to be exercising as a means of breaking the ‘hold’ that pregnancy had on them or ‘repairing’ their postpartum body,” Dr. Gow and her fellow researchers say. 

New Orleans resident Sydney Neal, 32, a mother of two who gave birth to her youngest child in November 2021, said social media helped shape her view of what “recovery” would be like.

While Ms. Neal said some celebrities like Chrissy Teigen, a mother of two, have “kept it very real” on Instagram, she also “saw a lot of women on social media drop [their weight] quickly and post as if they were back to normal much faster than 6 months.”
 

Body-positive tools for new moms 

Dr. Gow is continuing to study this topic. Her team is currently doing a study that will ask women about social media use, how they feel about their bodies, and how their beliefs change after viewing images tagged with #postpartumbody. (Women with children under the age of 2 can access the survey here.) 

Because of the unrealistic images, Dr. Gow and her team said Instagram may not be a good tool for sharing health information with new moms.

But there are other options. 

Ms. de Montille, whose children were born in 2020 and 2022, used apps like Back to You and Expectful, and she follows Karrie Locher, a postpartum and neonatal nurse and certified lactation counselor, on Instagram. She said these tools focus on the mind/body connection, which “is better than focusing on the size of your jeans.” 

Women also should be able to turn to trusted health care professionals.

“Providers can start speaking about the romanticization of pregnancy and motherhood starting in prenatal care, and they can start speaking more about social media use and the pros and cons of use specifically in the perinatal period,” says Dr. Fortney. “This opens the door to a discussion on a wide range of issues that can actually help assess, prevent, and treat perinatal mood and anxiety disorders.”

Ms. Neal, the mother of two in New Orleans, said she wished her doctor had talked to her more about what to expect after giving birth. 

“I don’t really know how to crack the body image nut, but I think starting in a medical setting might be helpful,” she says.

A version of this article first appeared on WebMD.com.

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Geographic location within the United States appears to have an impact on the specific symptoms of polycystic ovary syndrome (PCOS) that any one particular woman will develop, according to a new prospective cohort study.

Women in California were more likely to exhibit high levels of testosterone (hyperandrogenism), while women in Alabama with PCOS had more metabolic dysfunction and hirsutism.

And although the women in Alabama were younger and had a higher body mass index (BMI), even after adjusting for these factors, the clinical differences were still present between the geographic locations, the authors said.

“This study suggests there are regional differences in hormonal and metabolic parameters in women with PCOS in California and Alabama, highlighting the impact of differing genetic and environmental modulators on PCOS development,” Katherine VanHise, MD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues wrote in their article, published online in the Journal of Clinical Endocrinology and Metabolism.
 

Genetic and environmental factors play a role

Prior research has looked at variations in symptoms of PCOS across countries and identified differences in hirsutism and its prevalence, which is greater in Middle Eastern, Mediterranean, and Indian women, noted senior author Margareta D. Pisarska, MD.

And women of some other backgrounds “are at increased risk of developing metabolic syndrome and insulin resistance, including South Asian, African, and Hispanic women, so they are at a greater risk trajectory of developing manifestations later on in life that can ultimately lead to adverse outcomes in overall health,” Dr. Pisarska, director of the division of reproductive endocrinology and infertility in obstetrics and gynecology at Cedars-Sinai, told this news organization.

“We do see regional differences in the diagnosis of PCOS [in the United States] as well as the manifestations of PCOS including high andrenoemia, hirsutism, and metabolic parameters ... and we need to better understand it because, at least in the entire population, weight was not the entire factor contributing to these differences,” she explained.

“So there are definitely environmental factors and possibly genetic factors that we need to take into consideration as we try to study these women and try to help them decrease their risk of metabolic syndrome later in life,” she noted.
 

Differences not attributable to race either

PCOS is a common endocrine disorder affecting women and female adolescents worldwide. Diagnosis usually requires at least two of the following to be present: ovulatory dysfunction, hyperandrogenism, and/or polycystic ovarian morphology.

Because of the prior work that had identified differences in symptoms among women with PCOS in different countries, the investigators set out to determine if women of the same race would have distinct hormonal and metabolic traits of PCOS in two geographical locations in the United States, suggesting geo-epidemiologic contributors of the disease

They evaluated 889 women at the University of Alabama at Birmingham and 721 at Cedars-Sinai Medical Center. Participants in Birmingham were a mean age of 28 years, had a mean BMI of 33.1 kg/m2, a mean waist-to-hip ratio of 0.8, and a mean hirsute rate of 84.6%. Participants in California were a mean age of 29.5 years, had an average BMI of 30.1 kg/m2, a mean waist-to-hip ratio of 0.9, and a mean hirsute rate of 72.8%.

The study team gathered data on menstrual cycle history, metabolic and hormonal parameters, and demographic data for each participant. They assessed hirsutism based on modified Ferriman-Gallwey scores of four or more. Patients were classified as having hyperandrogenemia if they had elevated androgen values greater than the 95th percentile of all values or androgen values that exceeded laboratory reference ranges.

The findings showed that Alabama women with PCOS had elevated homeostatic model assessment for insulin resistance scores (adjusted beta coefficient, 3.6; P < .001) and were more likely to be hirsute (adjusted odds ratio, 1.8; P < .001) after adjustment for BMI and age than those in California.

In contrast, women with PCOS in California were more likely to have elevated free testosterone and total testosterone values than women in Alabama (both P < .001). These findings persisted after adjusting for age and BMI.

When stratified by White race, these findings were similar. Notably, BMI and waist-to-hip ratio did not vary between regions in Black women with PCOS, although variations in metabolic dysfunction and androgen profiles persisted.

“This study supports regional differences in hormonal and metabolic parameters in women with PCOS in the United States, highlighting the impact of the environment on PCOS phenotype. Individuals of the same race in different geographical locations of the United States may have differing genetic predispositions for developing diseases such as PCOS,” the researchers said.

“Ongoing research is needed to identify modifiable environmental risk factors for PCOS that may be race and ethnic specific to bring precision medicine to the management of PCOS,” they conclude.

This work was supported in part by grants from the National Institutes of Health and an endowment of the Helping Hand of Los Angeles. Dr. VanHise reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

CVS is cutting the cost of its store-branded menstrual products and paying state sales taxes on them in a dozen states.

The drug store chain said that starting Thursday it was reducing prices on CVS Health and Live Better tampons, menstrual pads, liners, and cups by 25%.

“Women deserve quality when it comes to the products they may need each month,” CVS said in a statement. “We’re paying the tax on period products on behalf of our customers where and when possible, and are working to help eliminate the tax nationwide.”

The store is also trying to equalize costs between men’s and women’s hygiene products, like razors.

The chain is paying sales taxes on period products in these 12 states: Arkansas, Georgia, Hawaii, Louisiana, Missouri, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.

It can’t pay the taxes in other states that have them because of laws that prevent third parties from paying taxes for a customer.

“This move will highlight their commitment to addressing women’s health and pave the way for reducing menstrual inequity,” Padmini Murthy, MD, the global health lead for the American Medical Women’s Association, said in an email to CNN, “and not just to promote the use of CVS products.”

Twenty-three states don’t tax feminine hygiene products, says the Alliance for Period Supplies, an advocacy group seeking to expand access to menstrual supplies.

“Too often period products are taxed as luxury items and not recognized as basic necessities,” the organization said. “Period products are taxed at a similar rate to items like decor, electronics, makeup, and toys.” 

Tampon prices rose 12.2% for the year ending Oct. 2, according to market research firm IRI. 

And 25% of women struggle to buy the products because of the expense, says the group.

A version of this article first appeared on WebMD.com.

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, dermatologists who prescribe isotretinoin, a teratogenic drug used to treat severe nodular acne, say they worry even more than in the past about their patients and the risk of accidental pregnancies. Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.

The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.

As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.

“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.

The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.

But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”

The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
 

Methotrexate prescriptions

Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.

The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”

“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”

The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.

Perspective: A Georgia dermatologist

Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.

That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.

In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.

Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”

Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
 

Perspective: An Arizona dermatologist

Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.

And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.

Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
 

Perspective: A Connecticut dermatologist

The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.

Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”

For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.

Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”

Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
 

Need for EC education

In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.

The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.

Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.

Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.

Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.