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FDA Panel Urges Caution on Antidepressant Use During Pregnancy
Experts weigh fetal risks of SSRIs as FDA panel pushes for stronger warnings on antidepressant use during pregnancy.

A federal advisory panel is calling on the Food and Drug Administration to issue stronger warnings about the use of antidepressants—specifically SSRIs—during pregnancy, citing potential links to birth complications such as miscarriage, autism, and organ development issues.
While medical guidelines have long held that the risks of untreated depression in pregnancy outweigh the risks of medication, some panel members argue it’s time to reconsider. “Serotonin plays a key role in fetal development, especially in the heart, brain, and gut,” said FDA Commissioner Marty Makary. “SSRIs may uniquely interact with that process.”
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Selective Serotonin Reuptake Inhibitors (SSRIs) are a widely prescribed class of antidepressants that work by boosting serotonin levels in the brain. Common brands include Zoloft, Prozac, and Lexapro.
The FDA panel suggested adding warning labels to clearly outline potential maternal and fetal risks, particularly for expectant mothers in their first trimester.
Still, many experts advise caution before making changes to treatment plans. Johns Hopkins Medicine notes that untreated mental illness can itself be harmful to both mother and baby. While SSRIs are not commonly linked to birth defects, about 30% of babies exposed in utero may develop neonatal adaptation syndrome—temporary symptoms like irritability and breathing issues in the first days after birth.
For now, the FDA has not issued any formal changes but is reviewing the panel’s recommendations.
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