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FDA Moves to Add Pregnancy Warning on Acetaminophen as Experts Counter Link to Autism

Medical societies and global regulators say current evidence does not warrant changing guidance for short‑term use in pregnancy.

Overview

  • The FDA says it has begun a labeling review to note studies suggesting prenatal acetaminophen use may be associated with autism and ADHD, while acknowledging causation is unproven.
  • President Trump publicly urged pregnant people to limit or avoid Tylenol, a message clinicians say has caused confusion and anxiety among patients.
  • The World Health Organization and European Medicines Agency reiterated there is no conclusive evidence that paracetamol in pregnancy causes autism, and their guidance remains unchanged.
  • Researchers highlight mixed observational findings, with a large sibling‑controlled JAMA study of about 2.5 million Swedish births finding no causal link, and a House panel of autism specialists rejecting the administration’s claims.
  • Obstetric and pediatric groups continue to recommend judicious, short‑term acetaminophen for fever and pain in pregnancy due to risks from untreated illness, while a YouGov poll found most Britons still view it as safe.