Should SSRIs Carry a Black Box Warning in Pregnancy? FDA Panel Sparks Controversy
🗓️ Context & Timeline
From July 21 to 25, 2025, the U.S. Food and Drug Administration convened a 10‑member expert panel to evaluate the safety of administering selective serotonin reuptake inhibitors (SSRIs) during pregnancy. The central question: should SSRIs carry a new, stronger warning label—similar to a “black box”—regarding potential risks to the fetus?
🗣️ Key Voices & Perspectives
FDA Commissioner Marty Makary, M.D., MPH opened with concerns that SSRIs have been linked in various studies to postpartum hemorrhage, pulmonary hypertension, and cardiac birth defects. He noted that up to 5% of pregnant women and nearly 25% of middle-aged women take antidepressants.
Panelists advocating stronger warnings, including Dr. Adam Urato of MetroWest Medical Center, emphasized fetal risks, stating:
“Never before in human history have we chemically altered developing babies like this … without any real public warning.”
Conversely, Dr. Kay Roussos‑Ross, the only panelist specializing in perinatal mood disorders, stressed the importance of SSRIs:
“For those that do need them, SSRIs are life‑changing and lifesaving… we should not withhold them.”
❓Evidence & Concerns Raised
Some panelists raised controversial claims including exaggerated associations between SSRI use and autism, fetal alcohol syndrome, and neurodevelopmental harm. Critics assert these statements lack credible scientific support and could mislead the public.
At the same time, critics argue the panel disproportionately featured dissenting voices—including individuals skeptical of antidepressants—while lacking representation from reproductive psychiatry experts. Only one clinician on the panel treats pregnant individuals with mental health conditions.
⚕️Responses from Medical Organizations
The American College of Obstetricians and Gynecologists (ACOG) strongly condemned the panel as “alarmingly unbalanced” and emphasized that there is robust evidence supporting the reproductive safety of SSRIs. They warned that expecting fear-based messaging could dissuade necessary treatment and risk maternal—and fetal—health.
The National Curriculum in Reproductive Psychiatry similarly noted that observational data do not support causal links between prenatal SSRI exposure and autism or birth defects.
The Science: Risk vs Benefit
⚠️Risks Cited by the Panel:
Potential associations with fetal cardiac malformations, pulmonary hypertension of the newborn (PPHN), neonatal adaptation syndrome (transient jitteriness and respiratory signs), and altered fetal brain development.
However, larger studies adjusting for confounding factors (e.g., severity of maternal depression, smoking, obesity) largely show no significant increase in birth defects or long-term neurodevelopmental harm.
🤰Consequences of Untreated Maternal Depression:
Complications such as preterm birth, low birth weight, poor prenatal care, substance use, and elevated risk of postpartum depression and suicide, which has become a leading cause of pregnancy-related death. Without psychiatric medication, up to 68% of women with a history of major depression relapse during pregnancy, compared with significantly lower relapse rates when medication is continued.
🧐What’s Next?
The FDA has not ruled on whether it will implement a black box warning, but the panel’s input is under active consideration. No formal decision or label change has been announced as of July 27, 2025.
🎓Bottom Line
The FDA panel reignited complex debates around SSRIs in pregnancy, with roughly half of its members advocating for stronger warning labels, emphasizing potential fetal risks. In contrast, major obstetrics and mental health organizations argue there is strong evidence supporting the careful use of SSRIs, particularly for women at high risk from untreated depression.
The key takeaway: Decisions on SSRI use in pregnancy must involve shared, individualized decision-making, balancing uncertain medication risks against the well-documented dangers of untreated maternal mental illness.
Reference:
- FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy (link)
- Becker’s Behavioral Health. (2025, July 23). FDA mulls ‘black box’ warning for antidepressant use in pregnancy. (link)
- Drug Topics. (2025, July 24). FDA Panel Weighs Risks, Benefits of SSRI Use During Pregnancy. (link)
- Medscape. (2025, July 24). FDA Panel Casts Doubt on Safety of SSRI Use in Pregnancy. (link)
- Los Angeles Times. (2025, July 23). FDA panel on SSRI antidepressants in pregnancy raises alarms. (link)
- STAT News. (2025, July 25). FDA panel raises concerns about SSRI antidepressant use in pregnancy. (link)
- MGH Center for Women’s Mental Health. (2025, July 25). Weighing the Evidence: Response to the FDA’s Recent Panel on SSRIs and Pregnancy. (link)
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