Doctors in the US will soon be advised not to prescribe Tylenol (paracetamol) to pregnant women, President Donald Trump said on Monday. He spoke in the Oval Office alongside Health Secretary Robert F. Kennedy Jr., citing studies that suggest a link between prenatal acetaminophen use and autism.
He called the rise in reported autism cases a “horrible crisis.”
Planned FDA actions and public messaging
Kennedy said the Food and Drug Administration will issue a physician notice on the potential risk.
He added the agency will begin a safety-label review and launch a public health campaign.
He also said the FDA will move to approve leucovorin, long used to reduce chemotherapy toxicity as a treatment for some children with autism.
Earlier this year, he pledged a broad push to study autism causes.
Evidence based associations, not causation via clinical trails
Some research has found an association between acetaminophen use in pregnancy and autism. However, findings remain inconsistent and inconclusive.
As a result, major medical groups still identify acetaminophen as one of the few options considered acceptable for fever and pain in pregnancy when used as directed.
The American College of Obstetricians and Gynecologists says studies do not show a proven causal link.
Doctors also warn that untreated fever can harm a fetus, so risk–benefit discussions remain key.
Industry stance and clinical guidance
Kenvue, which makes paracetamol, rejected the claimed link and warned that discouraging use could push expectant mothers toward riskier drugs or no treatment at all.
The company says independent science supports acetaminophen’s safety in pregnancy.
Meanwhile, experts caution that autism has no single known cause and likely arises from a mix of genetic and environmental factors.
The FDA has not given timelines for the physician notice, label language, or the public campaign.
For now, clinicians urge patients not to stop medication on their own. Instead, they recommend discussing symptoms, dosing, and alternatives during prenatal visits.
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