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Global Regulators Reject Trump’s Tylenol–Autism Claim as U.S. Issues Pregnancy Advisories

Officials say the evidence does not establish causation, warning that discouraging acetaminophen in pregnancy could jeopardize safe treatment of pain and fever.

Overview

  • After the White House said some autism cases may be linked to prenatal acetaminophen, the FDA moved to advise clinicians to use the lowest effective dose for the shortest duration and to update labeling, alongside an HHS public information campaign.
  • Europe’s EMA and the U.K.’s MHRA said they find no evidence that paracetamol in pregnancy causes autism and continue to recommend its use as directed, while the WHO cautioned against vaccine misinformation following the president’s separate comments about childhood shots.
  • Major medical groups, including ACOG, and Tylenol maker Kenvue criticized the administration’s message, noting acetaminophen remains the safest over‑the‑counter option in pregnancy and warning that avoiding it could lead to untreated fever or riskier NSAID use.
  • Researchers describe a mixed evidence base, with recent reviews reporting associations that cannot prove causation and a large 2024 Swedish sibling‑controlled JAMA study finding no link; authors of a cited review recommend judicious, medically guided use rather than avoidance.
  • The administration also promoted leucovorin for some autism‑related symptoms, with the FDA reapproving an older formulation and Medicaid set to cover it, even as experts stress that evidence for benefit in autism is preliminary and limited.