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FDA Moves to Add Pregnancy Warning to Acetaminophen as Trump Claims Draw Global Rebuke

Global regulators and U.S. medical groups say causation is unproven, urging pregnant patients to seek clinician guidance.

Overview

  • The FDA said it will update acetaminophen labels and advise using the lowest effective dose for the shortest time in pregnancy, while noting studies show associations but not causation and that contrary evidence exists.
  • European and U.K. regulators, along with the WHO, rejected claims of a proven link and continue to recommend paracetamol when appropriate, with experts warning that untreated fever or pain in pregnancy poses known risks.
  • President Trump told pregnant women not to take Tylenol and suggested spacing childhood vaccines, positions criticized by medical societies that reiterated vaccines do not cause autism and that treatment decisions should be made with doctors.
  • The FDA reapproved a decades‑old leucovorin formulation for cerebral folate deficiency, and the administration signaled Medicaid coverage, though experts say evidence for treating autism symptoms remains preliminary.
  • NIH announced $50 million in awards to 13 research teams for autism data science projects as part of the administration’s broader initiative.