FDA Panel's Discussion on Antidepressants in Pregnancy Sparks Controversy

On July 21, 2025, a panel convened by the Food and Drug Administration (FDA) to discuss the implications of antidepressant use during pregnancy has ignited significant controversy among medical professionals. The panel’s predominant focus on potential risks associated with selective serotonin reuptake inhibitors (SSRIs) has been criticized for presenting what many psychiatrists describe as misinformation or misconstrued facts.

The panel, which featured ten experts, reportedly leaned heavily towards highlighting dangers such as autism, miscarriages, and birth defects associated with SSRIs, while neglecting to adequately discuss the risks posed by untreated maternal depression. "The panel's emphasis on safety concerns was not evidence-based, nor did it balance the serious risks of untreated depression,” stated Dr. Joseph Goldberg, a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City.

Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia, expressed disappointment that the FDA included international panelists rather than domestic experts adept in the relevant medical literature. In response to criticisms, an FDA spokesperson defended the panel's integrity, emphasizing the expertise and independence of the scientists involved.

The FDA's Commissioner, Martin Makary, has committed to ensuring that policies reflect current scientific standards and protect public health.

Health and Human Services Secretary Robert F. Kennedy Jr. has also called for a probe into the long-term effects of antidepressants, citing potential risks outlined in his May 2025 report, which suggested significant repercussions from the use of antidepressants during childhood.

The discussion centered on SSRIs, which include widely prescribed medications like Lexapro, Prozac, and Zoloft. These medications are designed to enhance serotonin levels in the brain, thereby improving mood. The prevailing guidance from mental health professionals is to encourage women to continue SSRIs during pregnancy, as the dangers of untreated depression may surpass the potential risks associated with the medication. Nonetheless, this remains a personal choice for each patient.

Due to ethical constraints, randomized control trials of SSRIs during pregnancy are non-existent; thus, existing data primarily stems from observational studies and drug registries. Some infants exposed to SSRIs might experience symptoms such as irritability or difficulty feeding, commonly referred to as "neonatal adaptation syndrome." While there are studies indicating a slight increase in miscarriage risk linked to antidepressant use, others have found no correlation. Notably, there is no substantial evidence connecting SSRIs to autism or congenital abnormalities.

Dr. Nancy Byatt, a perinatal psychiatrist at UMass Chan Medical School, not involved in the panel, noted that women with a history of depression are more likely to experience symptom recurrence during pregnancy, which can lead to severe consequences such as self-harm or low birth weight.

Contrarily, some panelists, including David Healy, claimed SSRIs do not aid individuals suffering from severe depression, a statement that many psychiatrists, including Goldberg, have vehemently disputed. The panel also featured Roger McFillin, who controversially framed depression as an emotional response rather than a medical condition.

The American College of Obstetricians and Gynecologists (ACOG) has stated that SSRIs can be essential for some pregnant individuals. ACOG expressed concern about the panel’s imbalance, with only one member addressing the critical role of SSRIs in mitigating the potentially devastating effects of perinatal mood disorders.

Despite differing opinions within the panel, Dr. Kay Roussos-Ross, a psychiatrist and OB-GYN at the University of Florida College of Medicine, advocated for SSRIs, urging for an objective review of the available data.

Many psychiatrists outside the panel worry that the discussions could lead to regulatory actions that restrict access to SSRIs, potentially complicating care for pregnant individuals needing treatment. Dr. Lindsay Lebin, an assistant professor of psychiatry at the University of Colorado Anschutz Medical Campus, echoed these concerns, fearing that heightened warnings on SSRI labels could create further barriers for those seeking assistance.

Overall, the FDA panel’s discussion has underscored the contentious debate surrounding the use of antidepressants during pregnancy, revealing a schism between differing perspectives within the psychiatric community and raising critical questions about patient care and public health policy moving forward.