The recent FDA panel discussion on the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy has sparked considerable debate among healthcare professionals and the public alike. This panel aimed to weigh the risks and benefits associated with SSRIs, such as Lexapro and Prozac, in light of emerging concerns regarding potential adverse outcomes like autism, miscarriages, and birth defects . Critics argue that the emphasis on these risks overshadows the dangers posed by untreated maternal depression, which can lead to severe consequences for both mother and child .
FDA Commissioner Marty Makary, MD, MPH, opened the session by acknowledging that “nearly 1 in 4 middle-aged women are on an antidepressant, and up to 5% of women in pregnancy are on an antidepressant.” While recognizing the potential benefit of SSRIs, he cautioned that the broader picture of mental health in the United States has not improved despite increasing prescriptions. “The more antidepressants we prescribe, the more depression there is,” he said, adding, “We have to start talking about root causes.”
Anick Bérard, PhD, professor of Perinatal Epidemiology, University of Montreal, faculty of Pharmacy, and CHU Ste-Justine in Montreal, and adjunct professor at the Faculty of Medicine, Université Claude Bernard, stated that depression and anxiety in pregnancy are prevalent and require treatment. “Untreated depression and anxiety during pregnancy has been shown to be associated with an increased risk of postpartum depression,” she said. She emphasized the complexity of risk-benefit analysis for antidepressant use in pregnancy and noted that the absolute risk of outcomes such as miscarriage or autism remains low, even if relative risk appears elevated in some studies.
A spokesperson for the FDA said in a statement that the claim that the panel was one-sided was “insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.” The spokesperson added that FDA Commissioner Martin Makary “has an interest in ensuring policies reflect the latest gold standard science and protect public health.”
Health and Human Services Secretary Robert F. Kennedy Jr. has called for a probe into the risks of antidepressants. His “Make America Healthy Again” report in May claimed there were “potentially major long-term repercussions” associated with use of the drugs in childhood.
The panel discussion focused on a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which includes Lexapro, Prozac and Zoloft. The medications increase levels of serotonin, a chemical messenger in the brain that can improve mood.
Experts in psychiatry often advocate for the continuation of SSRI treatment during pregnancy due to the significant risks associated with untreated mental illness. Untreated depression can exacerbate maternal health issues and negatively impact fetal development . The panel's focus on potential medication risks without adequately addressing these factors has raised concerns about misinformation and a lack of consensus within the medical community regarding best practices for managing perinatal mood disorders.
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