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Experts Criticize FDA’s Unbalanced Review of SSRIs in Pregnancy

Medical groups warn the skewed risk assessment could prompt stricter regulations restricting pregnant patients’ access to essential depression treatment.

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Overview

  • The FDA assembled a 10-member panel in which nine members have publicly questioned SSRI safety and only one, Dr. Kay Roussos-Ross, urged that antidepressants remain a critical option for treating perinatal depression.
  • Panelists repeatedly cited unconfirmed associations between SSRI use and autism, miscarriages, and birth defects without acknowledging evidence that well-controlled studies find no such links.
  • Psychiatry associations and individual experts described the session as unbalanced and misleading, stressing that untreated depression poses serious risks including self-harm and adverse birth outcomes.
  • An FDA spokesperson defended the forum as independent and grounded in rigorous science, emphasizing that policy decisions adhere to gold-standard evidence.
  • Providers and advocacy groups warn the risk-focused discourse may lead to stricter warnings or access barriers that endanger care for pregnant patients.