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# Group Seeks Stronger Pregnancy Warning on Antidepressants
- URL: https://www.fdaweb.com/group-seeks-stronger-pregnancy-warning-on-antidepressants/
- Published: 2025-11-17T12:00:00.000Z
- Updated: 2026-09-14T15:26:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160228

Advocacy group Public Citizen is urging FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed serotonin reuptake inhibitor antidepressants, citing risks to newborns exposed *in utero*. In an 11/15 petition,the watchdog group asks the agency to strengthen safety information for both selective serotonin reuptake inhibitors (SSRIs) — such as fluoxetine, sertraline, paroxetine and citalopram — and serotonin-norepinephrine reuptake inhibitors (SNRIs), including venlafaxine and desvenlafaxine. Public Citizen notes that SSRIs are used by at least 6% of pregnant women in the U.S., exposing more than 215,000 fetuses annually, according to FDA-funded research.

The petition calls for updated warnings about poor neonatal adaptation syndrome (PNAS), a constellation of symptoms that can occur in newborns exposed to the antidepressants during the third trimester. Public Citizen says existing labeling understates both the frequency and potential severity of PNAS, which can involve respiratory distress, feeding problems, irritability, vomiting, hypoglycemia, temperature instability or seizures — and may persist beyond two weeks after birth.

The group recommends that pregnant patients taking the antidepressants be advised to deliver in a hospital where neonatal specialists are on hand. It also asks the FDA to warn against third-trimester co-administration of the drugs with benzodiazepines or other central nervous system depressants, which it says can worsen neonatal complications.

Public Citizen is also asking FDA to mandate a comprehensive post-marketing safety study evaluating both short- and long-term outcomes for infants exposed to antidepressant in pregnancy. Until stronger evidence emerges, the group argues, labeling should emphasize that they be used only when benefits outweigh risks — while acknowledging the dangers of untreated maternal mental illness.

The petition advises clinicians and patients to use the lowest effective dose for the shortest duration if treatment is necessary, and warns against abrupt discontinuation, which can trigger withdrawal or relapse.