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White House Ties Prenatal Tylenol to Autism as FDA Moves to Change Labels

Global regulators and major medical groups say the evidence remains observational, advising pregnant patients to stick with current guidance.

Overview

  • President Donald Trump urged pregnant women to avoid acetaminophen and floated vaccine changes, while offering no new data to support a causal link to autism.
  • The FDA said associations have been reported but causation is unproven and announced it will pursue an acetaminophen label change, even as it cautioned that contrary studies exist.
  • Health agencies in the UK and EU and the WHO said paracetamol remains appropriate in pregnancy when used as directed and warned that misinformation can endanger public health.
  • Researchers note mixed observational findings, with a large Swedish sibling-controlled study finding no link after accounting for family confounding, and authors of cited reviews recommending judicious, short-term use under medical guidance.
  • ACOG, SMFM and pediatric groups criticized the announcement as misleading, stressing the dangers of untreated fever in pregnancy and reaffirming that vaccines do not cause autism.