Antidepressants and Pregnancy

The Associated Press reports that FDA’s top drug regulator, Dr. Tracy Beth Hoeg, is actively advancing a petition to add a boxed warning about alleged pregnancy risks to SSRI antidepressants while simultaneously trying to hire the petition’s author, maternal‑fetal specialist Dr. Adam Urato, as a full‑time FDA employee. Urato’s filing urges the agency to warn that SSRIs can cause miscarriages and fetal brain abnormalities leading to autism and other disorders, but outside experts say the case rests on weak animal and small human studies and ignores the serious dangers of untreated depression in pregnancy. Internal FDA critics view Hoeg’s close collaboration with Urato — including presenting his slide deck as her own in a talk to senior officials — as a clear conflict that would normally require her recusal, yet she is described as pushing to speed the review instead. The stakes are high: SSRIs such as Prozac, Paxil and Zoloft are the most commonly prescribed antidepressants, and federal data show more than 15% of U.S. women, about 26 million people, use depression medications, with current professional guidelines generally deeming them safe in pregnancy when carefully managed. The article also notes that Urato was recently appointed to a CDC vaccine‑advisory panel that Health Secretary Robert F. Kennedy Jr. has reshaped with vaccine‑skeptic voices, and that Hoeg herself rose to prominence criticizing COVID masks and vaccine mandates, deepening concerns that MAHA‑aligned ideology is bleeding into core FDA safety decisions.