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WHO, EMA Reaffirm Paracetamol Guidance After U.S. Cites Possible Autism Risk

Global health authorities say inconsistent pregnancy data fails to prove causation, leaving standard use acceptable under current advice.

Overview

  • President Donald Trump urged pregnant women to avoid Tylenol, while the FDA began a label‑change process and notified physicians about a possible association with autism and ADHD.
  • WHO said observational studies on prenatal acetaminophen and autism show inconsistent findings and warned that vaccines do not cause autism or warrant changes to immunisation schedules.
  • Europe’s medicines regulator said recommendations are unchanged, stating there is no evidence paracetamol in pregnancy causes autism and it remains an option at the lowest effective dose.
  • Kenvue, the maker of Tylenol, rejected any causal link and expressed concern that discouraging necessary treatment could harm pregnant patients.
  • Experts highlighted mixed research, noting a large 2024 Swedish sibling study found no causal association, and the FDA also advanced action to allow leucovorin use for cerebral folate deficiency.