Overview

• An FDA advisory panel convened on July 21 to consider a black box warning for SSRIs in pregnancy but has not recommended any labeling changes.
• The American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine and American Psychiatric Association condemned the panel’s risk assessments as unbalanced and fear-inducing.
• Perinatal psychiatrists warn that overstated fetal risk claims could deter treatment for depression affecting 11.5% of pregnancies and increase risks like preterm birth and maternal suicide.
• Large meta-analyses find no significant rise in major birth defects from prenatal SSRI use and report that mild neonatal adaptation syndrome resolves quickly with routine care.
• In the absence of formal FDA guidance, advocacy groups and clinicians are filling policy gaps by emphasizing evidence-based, individualized risk-benefit discussions.