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FDA considers warning about antidepressants during pregnancy

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July 28, 2025
in Health Care
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FDA considers warning about antidepressants during pregnancy

(NewsNation) — An advisory panel has urged the Federal Drug Administration to warn against the use of antidepressants in pregnant women.

The medical consensus thus far has been that antidepressants are safe, and the risks of untreated depression outweigh the slight risks to pregnancy. However, some panelists last week said the drugs present risks of autism, miscarriage and birth defects.

They flagged the possible negative interactions between the drug and fetal development.

“SSRIs may be unique because serotonin may have an interaction with the physiology of a woman and a woman who is pregnant,” said FDA Commissioner Marty Makary. “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain and even the gut.”


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Selective Serotonin Reuptake Inhibitors, or SSRIs, are a class of medications used to treat depression by increasing serotonin levels in the brain.

Some panelists proposed adding warning labels to medication bottles about adverse maternal and fetal risks during pregnancy.

Are antidepressants dangerous for pregnant women?

“There is generally no need to taper off medications during pregnancy, because antidepressants have not been known to cause birth defects,” according to Johns Hopkins Medicine. “In fact, untreated mental illness itself poses risks to a developing fetus.”

While most experts in the medical field have found SSRIs to be largely safe for pregnant women and their unborn babies, about 30% of babies whose mothers take them will experience neonatal adaptation syndrome. The condition can cause increased jitteriness, irritability and difficulty breathing, according to Johns Hopkins, but doctors aren’t sure whether this is due to the baby’s withdrawal from the SSRI after birth or exposure to the drug before birth.


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Some organizations have criticized the panel’s recommendations as misinformed and have said it disregarded risks associated with untreated depression in mothers.

“For pregnant people who need SSRIs, they are life-changing and lifesaving. Mental health conditions are already the most frequent cause of pregnancy-related death,” said Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, in a statement. “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.”

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