News from the FDA/CDC

Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”

Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”

Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”

Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.

The once-daily dual-action tablet is the first-and-only orally administered treatment combining the PARP inhibitor niraparib with abiraterone acetate.

Olivier Le Moal/Getty Images

The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.

Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.

Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.

The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).

An adverse reaction led to permanent discontinuation of treatment in 15% of patients.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”

About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.

The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.

The once-daily dual-action tablet is the first-and-only orally administered treatment combining the PARP inhibitor niraparib with abiraterone acetate.

Olivier Le Moal/Getty Images

The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.

Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.

Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.

The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).

An adverse reaction led to permanent discontinuation of treatment in 15% of patients.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”

About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.

The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.

The once-daily dual-action tablet is the first-and-only orally administered treatment combining the PARP inhibitor niraparib with abiraterone acetate.

Olivier Le Moal/Getty Images

The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.

Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.

Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.

The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).

An adverse reaction led to permanent discontinuation of treatment in 15% of patients.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”

About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.

The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved the first oral agent specifically for postpartum depression, a condition that affects an estimated one in seven mothers in the United States.

The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.

Olivier Le Moal/Getty Images

Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.

FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).

Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.

The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.

The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.

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

The Food and Drug Administration has approved the first oral agent specifically for postpartum depression, a condition that affects an estimated one in seven mothers in the United States.

The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.

Olivier Le Moal/Getty Images

Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.

FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).

Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.

The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.

The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.

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

The Food and Drug Administration has approved the first oral agent specifically for postpartum depression, a condition that affects an estimated one in seven mothers in the United States.

The pill, zuranolone (Zurzuvae), is a neuroactive steroid that acts on GABAA receptors in the brain responsible for regulating mood, arousal, behavior, and cognition, according to Biogen, which, along with Sage Therapeutics, developed the product. The recommended dose for Zurzuvae is 50 mg taken once daily for 14 days, in the evening with a fatty meal, according to the FDA.

Olivier Le Moal/Getty Images

Postpartum depression often goes undiagnosed and untreated. Many mothers are hesitant to reveal their symptoms to family and clinicians, fearing they’ll be judged on their parenting. A 2017 study found that suicide accounted for roughly 5% of perinatal deaths among women in Canada, with most of those deaths occurring in the first 3 months in the year after giving birth.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement about the approval. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

The other approved therapy for postpartum depression is the intravenous agent brexanolone (Zulresso; Sage). But the product requires prolonged infusions in hospital settings and costs $34,000.

FDA approval of Zurzuvae was based in part on data reported in a 2023 study in the American Journal of Psychiatry, which showed that the drug led to significantly greater improvement in depressive symptoms at 15 days compared with the placebo group. Improvements were observed on day 3, the earliest assessment, and were sustained at all subsequent visits during the treatment and follow-up period (through day 42).

Patients with anxiety who received the active drug experienced improvement in related symptoms compared with the patients who received a placebo.

The most common adverse events reported in the trial were somnolence and headaches. Weight gain, sexual dysfunction, withdrawal symptoms, and increased suicidal ideation or behavior were not observed.

The packaging for Zurzuvae will include a boxed warning noting that the drug can affect a user’s ability to drive and perform other potentially hazardous activities, possibly without their knowledge of the impairment, the FDA said. As a result, people who use Zurzuvae should not drive or operate heavy machinery for at least 12 hours after taking the pill.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

The U.S. Food and Drug Administration has approved an injectable monoclonal antibody to protect newborns and infants against respiratory syncytial virus (RSV).

The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.

As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.

The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.

Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.

Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).

The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.

“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”

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

Nearly 9 out of every 100 U.S. children are now diagnosed with a developmental disability, according to updated figures from the CDC. 

Developmental disabilities include autism, intellectual disabilities such as Down syndrome, and a range of other diagnoses related to missing developmental milestones in how a child plays, learns, or speaks.

The newly reported increase amounts to just over 1 percentage point from 2019 to 2021. In 2019, the rate of developmental disability diagnoses was about 7 in 100 children. The latest figures are from 2021 data, published this week after the CDC finished analyzing responses to the National Health Survey.

Among children ages 3-17 years old in 2021, the survey showed that:

• 1.7% had an intellectual disability.
• 3.1% had autism spectrum disorder.
• 6.1% had a diagnosis of “other developmental delay.”

No significant change was seen from 2019 to 2021 in how common it was for survey respondents to report children having autism or an intellectual disability. The overall increase was driven by a jump in reports from parents that a doctor or health professional told them their child had “any other developmental delay,” excluding autism spectrum disorder or an intellectual disability.

“A lot of times developmental delays might be temporary diagnoses that evolve into something like autism, potentially, or intellectual disability. But also a lot of times children do age out of those,” lead report author and CDC statistician Benjamin Zablotsky, PhD, told CBS News.

The CDC offers an app called Milestone Tracker to help parents watch for signs of developmental delays, in addition to operating a public health education program called “Learn the Signs. Act Early.”

The new report showed that boys were nearly twice as likely as girls to have any developmental delay, a pattern that was magnified when looking specifically at autism diagnoses. Boys were more than three times as likely as girls to be diagnosed with autism spectrum disorder. The rate of autism among boys was 4.7%, compared with 1.5% among girls.

While these latest survey results showed consistent rates of autism from 2019 to 2021, a different CDC report earlier this year showed an alarming jump in the rate of autism spectrum disorder among 8-year-olds. That report, which compared data from 2008 to 2020, showed the rate of autism among 8-year-olds rose during those 12 years from 1 in 88 kids to 1 in 36 kids.

The two analyses also differed in their findings regarding prevalence of autism when looking at children by race and ethnicity. The report from earlier this year showed that Black and Hispanic children were more likely to be diagnosed with autism, compared with White children. This latest report did not find any differences in the prevalence of autism based on a child’s race or ethnicity.

A version of this article appeared on WebMD.com.

Nearly 9 out of every 100 U.S. children are now diagnosed with a developmental disability, according to updated figures from the CDC. 

Developmental disabilities include autism, intellectual disabilities such as Down syndrome, and a range of other diagnoses related to missing developmental milestones in how a child plays, learns, or speaks.

The newly reported increase amounts to just over 1 percentage point from 2019 to 2021. In 2019, the rate of developmental disability diagnoses was about 7 in 100 children. The latest figures are from 2021 data, published this week after the CDC finished analyzing responses to the National Health Survey.

Among children ages 3-17 years old in 2021, the survey showed that:

• 1.7% had an intellectual disability.
• 3.1% had autism spectrum disorder.
• 6.1% had a diagnosis of “other developmental delay.”

No significant change was seen from 2019 to 2021 in how common it was for survey respondents to report children having autism or an intellectual disability. The overall increase was driven by a jump in reports from parents that a doctor or health professional told them their child had “any other developmental delay,” excluding autism spectrum disorder or an intellectual disability.

“A lot of times developmental delays might be temporary diagnoses that evolve into something like autism, potentially, or intellectual disability. But also a lot of times children do age out of those,” lead report author and CDC statistician Benjamin Zablotsky, PhD, told CBS News.

The CDC offers an app called Milestone Tracker to help parents watch for signs of developmental delays, in addition to operating a public health education program called “Learn the Signs. Act Early.”

The new report showed that boys were nearly twice as likely as girls to have any developmental delay, a pattern that was magnified when looking specifically at autism diagnoses. Boys were more than three times as likely as girls to be diagnosed with autism spectrum disorder. The rate of autism among boys was 4.7%, compared with 1.5% among girls.

While these latest survey results showed consistent rates of autism from 2019 to 2021, a different CDC report earlier this year showed an alarming jump in the rate of autism spectrum disorder among 8-year-olds. That report, which compared data from 2008 to 2020, showed the rate of autism among 8-year-olds rose during those 12 years from 1 in 88 kids to 1 in 36 kids.

The two analyses also differed in their findings regarding prevalence of autism when looking at children by race and ethnicity. The report from earlier this year showed that Black and Hispanic children were more likely to be diagnosed with autism, compared with White children. This latest report did not find any differences in the prevalence of autism based on a child’s race or ethnicity.

A version of this article appeared on WebMD.com.

Nearly 9 out of every 100 U.S. children are now diagnosed with a developmental disability, according to updated figures from the CDC. 

Developmental disabilities include autism, intellectual disabilities such as Down syndrome, and a range of other diagnoses related to missing developmental milestones in how a child plays, learns, or speaks.

The newly reported increase amounts to just over 1 percentage point from 2019 to 2021. In 2019, the rate of developmental disability diagnoses was about 7 in 100 children. The latest figures are from 2021 data, published this week after the CDC finished analyzing responses to the National Health Survey.

Among children ages 3-17 years old in 2021, the survey showed that:

• 1.7% had an intellectual disability.
• 3.1% had autism spectrum disorder.
• 6.1% had a diagnosis of “other developmental delay.”

No significant change was seen from 2019 to 2021 in how common it was for survey respondents to report children having autism or an intellectual disability. The overall increase was driven by a jump in reports from parents that a doctor or health professional told them their child had “any other developmental delay,” excluding autism spectrum disorder or an intellectual disability.

“A lot of times developmental delays might be temporary diagnoses that evolve into something like autism, potentially, or intellectual disability. But also a lot of times children do age out of those,” lead report author and CDC statistician Benjamin Zablotsky, PhD, told CBS News.

The CDC offers an app called Milestone Tracker to help parents watch for signs of developmental delays, in addition to operating a public health education program called “Learn the Signs. Act Early.”

The new report showed that boys were nearly twice as likely as girls to have any developmental delay, a pattern that was magnified when looking specifically at autism diagnoses. Boys were more than three times as likely as girls to be diagnosed with autism spectrum disorder. The rate of autism among boys was 4.7%, compared with 1.5% among girls.

While these latest survey results showed consistent rates of autism from 2019 to 2021, a different CDC report earlier this year showed an alarming jump in the rate of autism spectrum disorder among 8-year-olds. That report, which compared data from 2008 to 2020, showed the rate of autism among 8-year-olds rose during those 12 years from 1 in 88 kids to 1 in 36 kids.

The two analyses also differed in their findings regarding prevalence of autism when looking at children by race and ethnicity. The report from earlier this year showed that Black and Hispanic children were more likely to be diagnosed with autism, compared with White children. This latest report did not find any differences in the prevalence of autism based on a child’s race or ethnicity.

A version of this article appeared on WebMD.com.

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

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

This article was updated 7/13/23.

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

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

This article was updated 7/13/23.

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

Olivier Le Moal/Getty Images

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.

Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.

The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”

But doctors largely disagreed.

“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.

While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.

Pricing unknown

Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.

“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.

Caveats to consider

There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.

Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”

Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.

The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.

Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”

Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”

Just the beginning?

The American Medical Association hopes this approval signals more to come.

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”

The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.

“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.

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

This article was updated 7/13/23.