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U.S. infant mortality rates rise for first time in 2 decades
The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.
Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.
“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”
Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.
The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.
“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.
“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.
“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”
A version of this article first appeared on WebMD.com.
The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.
Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.
“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”
Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.
The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.
“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.
“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.
“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”
A version of this article first appeared on WebMD.com.
The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.
Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.
“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”
Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.
The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.
“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.
“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.
“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”
A version of this article first appeared on WebMD.com.
FDA OKs Paradise Renal Denervation system for hypertension
Recor Medical and parent company Otsuka Medical Devices have announced.
Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications. 
Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.
Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.
The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.
“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.
Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.
The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.
A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.
A version of this article first appeared in Medscape.com.
Recor Medical and parent company Otsuka Medical Devices have announced.
Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.
Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.
Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.
The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.
“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.
Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.
The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.
A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.
A version of this article first appeared in Medscape.com.
Recor Medical and parent company Otsuka Medical Devices have announced.
Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.
Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.
Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.
The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.
“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.
Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.
The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.
A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.
A version of this article first appeared in Medscape.com.
FDA approves tirzepatide for treating obesity
Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m2 or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.
Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.
The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.
Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.
Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.
Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.
The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.
Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.
A version of this article first appeared on Medscape.com.
Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m2 or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.
Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.
The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.
Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.
Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.
Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.
The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.
Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.
A version of this article first appeared on Medscape.com.
Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m2 or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.
Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.
The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.
Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.
Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.
Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.
The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.
Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.
A version of this article first appeared on Medscape.com.
Test all perinatally exposed infants for HCV: CDC
In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.
HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).
About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.
This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
The new recommendations
- Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
- Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
- Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.
“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
A growing problem
The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.
Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.
The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.
In her view, mothers will likely be quite accepting of testing for their infants. “It could be integrated into the routine newborn screening panel, so there should not be barriers to accessibility if they’re getting prenatal and neonatal care.”
Commenting on HCV testing for babies in an interview at his institution, Ravi R. Jhaveri, MD, division head of pediatric infectious diseases at Northwestern Medicine’s Ann & Robert H. Lurie Children’s Hospital of Chicago, said, “This is a terrific way to capitalize on the fact that infants already come to the doctor for many visits during the first months of life for their vaccines and their well-child check. And so this should be an easy way to streamline our testing strategy and hopefully lose many fewer patients.”
Northwestern Medicine is an innovative clinic offering HCV testing and treatment outside of clinical trials for pregnant women and their infants with the goal of preventing transmission from mother to child.
Northwestern is launching a clinical trial of treatment for HCV-positive pregnant patients during regular prenatal care. “With very simple treatments similar to taking a prenatal vitamin, it would be easy and seamless to fit into the existing schedule,” said Lyn Yee, MD, a Northwestern maternal-fetal medicine specialist.
Dr. Yee stressed that eliminating hepatitis C will likely be one of the most significant health advancements of the decade.
Dr. Lewis, Dr. Jhaveri, and Dr. Yee had no relevant conflicts of interest to declare with regard to their comments.
In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.
HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).
About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.
This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
The new recommendations
- Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
- Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
- Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.
“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
A growing problem
The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.
Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.
The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.
In her view, mothers will likely be quite accepting of testing for their infants. “It could be integrated into the routine newborn screening panel, so there should not be barriers to accessibility if they’re getting prenatal and neonatal care.”
Commenting on HCV testing for babies in an interview at his institution, Ravi R. Jhaveri, MD, division head of pediatric infectious diseases at Northwestern Medicine’s Ann & Robert H. Lurie Children’s Hospital of Chicago, said, “This is a terrific way to capitalize on the fact that infants already come to the doctor for many visits during the first months of life for their vaccines and their well-child check. And so this should be an easy way to streamline our testing strategy and hopefully lose many fewer patients.”
Northwestern Medicine is an innovative clinic offering HCV testing and treatment outside of clinical trials for pregnant women and their infants with the goal of preventing transmission from mother to child.
Northwestern is launching a clinical trial of treatment for HCV-positive pregnant patients during regular prenatal care. “With very simple treatments similar to taking a prenatal vitamin, it would be easy and seamless to fit into the existing schedule,” said Lyn Yee, MD, a Northwestern maternal-fetal medicine specialist.
Dr. Yee stressed that eliminating hepatitis C will likely be one of the most significant health advancements of the decade.
Dr. Lewis, Dr. Jhaveri, and Dr. Yee had no relevant conflicts of interest to declare with regard to their comments.
In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.
HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).
About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.
This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
The new recommendations
- Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
- Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
- Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.
“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
A growing problem
The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.
Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.
The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.
In her view, mothers will likely be quite accepting of testing for their infants. “It could be integrated into the routine newborn screening panel, so there should not be barriers to accessibility if they’re getting prenatal and neonatal care.”
Commenting on HCV testing for babies in an interview at his institution, Ravi R. Jhaveri, MD, division head of pediatric infectious diseases at Northwestern Medicine’s Ann & Robert H. Lurie Children’s Hospital of Chicago, said, “This is a terrific way to capitalize on the fact that infants already come to the doctor for many visits during the first months of life for their vaccines and their well-child check. And so this should be an easy way to streamline our testing strategy and hopefully lose many fewer patients.”
Northwestern Medicine is an innovative clinic offering HCV testing and treatment outside of clinical trials for pregnant women and their infants with the goal of preventing transmission from mother to child.
Northwestern is launching a clinical trial of treatment for HCV-positive pregnant patients during regular prenatal care. “With very simple treatments similar to taking a prenatal vitamin, it would be easy and seamless to fit into the existing schedule,” said Lyn Yee, MD, a Northwestern maternal-fetal medicine specialist.
Dr. Yee stressed that eliminating hepatitis C will likely be one of the most significant health advancements of the decade.
Dr. Lewis, Dr. Jhaveri, and Dr. Yee had no relevant conflicts of interest to declare with regard to their comments.
High school students using less tobacco, vape products, CDC report shows
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
which have been shown to both entice teens and keep them vaping.
METHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
FDA to health care providers: Double-check COVID vaccine dose for children
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.
That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”
The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.
“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.
Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.
“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.
A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
No safety risks identified
“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.
“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
One parent’s experience
Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.
A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
Perhaps more reactions, no danger
“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”
If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”
Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”
The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”
A version of this article appeared on Medscape.com.
FDA OKs new treatment for erosive esophagitis
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.
Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.
The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.
In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.
In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).
Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.
The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.
Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.
Vonoprazan is expected to be available in the United States in December.
The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.
In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.
Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.
FDA OKs first ustekinumab biosimilar
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
FDA approves abatacept for pediatric patients with psoriatic arthritis
The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.
Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.
“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.
Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.
This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.
“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.
Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.
“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.
Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.
This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.
“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients aged 2 years and older.
Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.
“The FDA’s approval of expanding Orencia’s indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage,” said Carlos Dortrait, senior vice president of U.S. immunology at Bristol-Myers Squibb in a statement. BMS is the manufacturer of abatacept.
Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.
This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with RA, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2-17 years with pJIA.
“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement. “The FDA’s approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and health care professionals.”
A version of this article first appeared on Medscape.com.
FDA warns of hidden ingredients in arthritis, pain products
Some of these products contain active ingredients found in anti-inflammatory prescription medication.
“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”
Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.
From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.
Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.
“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”
Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.
These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.
The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
Advising patients
Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.
He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.
Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.
If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Tips for safe shopping
To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:
- Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
- Avoid buying products with labels in another language that you cannot read or products with no drug label.
- Be cautious of buying products online or from other countries.
- Look up suspicious products on the FDA’s health fraud database.
- Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.
In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.
Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.
Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.
Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.
“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”
Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Some of these products contain active ingredients found in anti-inflammatory prescription medication.
“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”
Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.
From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.
Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.
“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”
Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.
These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.
The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
Advising patients
Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.
He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.
Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.
If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Tips for safe shopping
To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:
- Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
- Avoid buying products with labels in another language that you cannot read or products with no drug label.
- Be cautious of buying products online or from other countries.
- Look up suspicious products on the FDA’s health fraud database.
- Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.
In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.
Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.
Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.
Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.
“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”
Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Some of these products contain active ingredients found in anti-inflammatory prescription medication.
“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”
Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. Only after a complaint is made or FDA testing reveals illegal or unsafe ingredients can the FDA get involved.
From August 2013 to September 2023, the FDA identified 22 arthritis and pain products with active ingredients not disclosed on the product label. The most common hidden ingredients detected in these supplements were prescription-only corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants, said Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the University of California, San Francisco.
Kuka Flex Forte and Reumo Flex, both promoted for joint pain and arthritis, both contain the NSAID diclofenac. Tapee Tea, a product promoted for pain relief, contains dexamethasone and piroxicam. AK Forte, also sold for joint pain and arthritis, contains diclofenac, dexamethasone, and methocarbamol not disclosed on the label.
“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Dr. Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”
Certain products also contained antihistamines including cyproheptadine and chlorpheniramine.
These types of products are likely targeted toward underserved and immigrant communities, added Pieter Cohen, MD, a primary care physician and an assistant professor of medicine at Harvard Medical School, Boston, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to individuals with limited access to health care or insurance, he noted.
The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
Advising patients
Research suggests that most patients do not tell doctors about the supplements they are taking, and often, clinicians do not ask, said Dr. Cohen. “Most of the time it’s a total black box – we don’t know what’s going on,” he added.
He advised raising the subject of supplements in a very nonjudgmental way, particularly when treating patients in marginalized and immigrant communities. One approach he suggested was first mentioning that other patients in your care dealing with joint pain have bought remedies locally or have tried treatments that friends recommend. You can then ask a patient about their own use, framing it as a way to better help with treatment decisions.
Once a clinician understands what their patient is taking, they can then give advice and discuss if a product is safe to combine with prescription drugs, Dr. Cohen said. “If they come down too hard, I think the patients will just clam up and not talk about it anymore,” he said.
If a patient begins to experience side effects or gets sick, a clinician will already be informed of what their patient is taking and can ask that patient to bring the product or supplement in, so they can look over the product together, Dr. Cohen noted. Any side effects or other adverse events potentially related to the use of these products should then be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Tips for safe shopping
To make sure supplements and other over-the-counter products are safe to use, Dr. Tsourounis recommends that consumers:
- Buy products from well-known retailers like Target or large pharmacies like CVS or Walgreens.
- Avoid buying products with labels in another language that you cannot read or products with no drug label.
- Be cautious of buying products online or from other countries.
- Look up suspicious products on the FDA’s health fraud database.
- Be wary of any product that offers miracle cures or relies on personal testimonies without evidence.
In general, do not base purchasing decisions on any health claims on a product label because companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Dr. Cohen said.
Dr. Cohen also recommends sticking with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run [you] into trouble,” he said.
Last, Dr. Cohen recommended buying supplements that are certified by NSF International or United States Pharmacopeia, both respected third-party testing organizations. “If it has an NSF International or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.
Dr. Tsourounis noted that if you are skeptical of a product, you can also try calling the manufacturer number on the product label.
“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”
Dr. Cohen has received research support from the Consumers Union and PEW Charitable Trusts and royalties from UpToDate. He has collaborated in research with NSF International. Dr. Tsourounis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.