FDA Panel Debates Black Box Warning on Antidepressants During Pregnancy

A recent FDA panel discussion on the use of antidepressants, specifically SSRIs, during pregnancy highlighted significant controversy within the medical community regarding their safety and risks. While some panelists emphasized potential risks such as autism, birth defects, and behavioral issues in offspring, many experts stressed that untreated maternal depression poses greater health risks and that the absolute risks from SSRI use remain low. FDA Commissioner Marty Makary noted the high prevalence of antidepressant use among pregnant women and called for addressing root causes of depression, while acknowledging the complexity of balancing benefits and risks. The debate also reflected a shift under Health and Human Services Secretary Robert F. Kennedy Jr., who prioritizes reducing psychotropic drug prescriptions. Despite calls from some panelists for stronger warnings, including a possible black box label, the FDA has not confirmed any regulatory changes. Overall, the discussion underscored the need for nuanced communication to pregnant women about the benefits and potential risks of antidepressant use, amid ongoing scientific uncertainty and differing expert opinions.