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FDA eyes warning label for antidepressants during pregnancy

14 24
14.08.2025

The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, alarming some doctors who worry that a reignited debate about the drugs’ safety will discourage pregnant people from seeking treatment.

FDA Commissioner Marty Makary recently hosted a panel discussion about the use of antidepressants during pregnancy, specifically serotonin reuptake inhibitors (SSRIs), with participants challenging the scientific consensus.

While the drugs may pose some risk during pregnancy, the risks associated with not treating mood disorders like depression, to both pregnant people and developing fetuses, are much higher, according to physicians and medical experts.

The American College of Obstetricians and Gynecologists (ACOG) released a statement calling the discussion “alarmingly unbalanced,” warning that it is dangerous to minimize the effects of mental health conditions during pregnancy and postpartum.

“Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need,” the statement reads.

Many panelists suggested pregnant people should be better warned about the harms the drugs pose to a developing fetus and discussed changing current labeling on antidepressants.

Makary said in his opening remarks the drugs could influence the development of organs like the brain and heart in utero. He added that SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary........

© The Hill