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White House Moves to Caution on Prenatal Tylenol Use as Regulators Reject Autism Link

The FDA itself says associations in studies have not established causation.

Overview

  • Federal officials said the FDA will notify clinicians to limit acetaminophen in pregnancy to the lowest effective dose for the shortest time and will begin updating labels.
  • Major medical bodies and regulators, including ACOG, SMFM, the EMA and the UK MHRA, said paracetamol remains recommended for pregnant patients and that no evidence shows it causes autism.
  • The FDA noted that some studies report associations but emphasized contrary evidence, including a 2024 Swedish sibling-controlled JAMA study that found no causal link.
  • The administration moved to expand access to leucovorin for autistic symptoms tied to cerebral folate deficiency and said Medicaid programs will cover it, while autism researchers called the evidence preliminary and urged rigorous trials.
  • Clinicians warned that discouraging acetaminophen could leave fevers and severe pain untreated during pregnancy and condemned renewed suggestions of a vaccine–autism link as false.