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53m ago

FDA Moves to Add Prenatal Tylenol Warning as Officials Temper Message and Doctors Stress Judicious Use

Clinicians emphasize acetaminophen remains the safest option to treat fever in pregnancy and warn that avoiding it or substituting riskier drugs could cause harm.

File photo: Centers for Medicare and Medicaid Services administrator Dr. Mehmet Oz speaks in the Roosevelt Room of the White House, pm September 22, 2025, in Washington, during an event with President Donald Trump.
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Areva Martin is a civil rights attorney, founder and president of Special Needs Network (SNN), and mother of a young adult son on the autism spectrum.

Overview

  • President Donald Trump urged pregnant women to avoid Tylenol, but CMS administrator Dr. Mehmet Oz said federal guidance does not advise blanket avoidance and that patients should take it if a clinician recommends it, especially for high fevers.
  • An FDA letter told physicians that prenatal acetaminophen use may be associated with higher risks of autism and ADHD, while stating causation is unproven and advising clinicians to minimize use for routine low-grade fevers.
  • Major medical groups, including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, continue to back acetaminophen as the safest over-the-counter option in pregnancy when used at the lowest effective dose for the shortest time.
  • The White House and HHS resurfaced a 2017 Tylenol post suggesting nonuse in pregnancy; maker Kenvue said the old tweet was taken out of context and reiterated that independent research does not show acetaminophen causes autism.
  • Scientists caution that untreated fever in pregnancy carries known risks, and the evidence on acetaminophen is mixed, with a large 2024 Swedish sibling study finding no causal link and a 2025 Mount Sinai review reporting consistent associations.