Trump announces FDA to revise Tylenol safety label, urges pregnant women to avoid use over autism risk

WASHINGTON — President Donald Trump announced Monday that the Food and Drug Administration will update the safety labeling on Tylenol to reflect research linking acetaminophen use during pregnancy with autism. He urged expecting mothers to avoid taking the drug for the entire duration of pregnancy, saying the only time it should be taken is during a high-risk fever and with the lowest possible dose if there is no alternative.

Speaking at the Roosevelt Room of the White House with Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, Trump said, "With Tylenol, don’t take it! Don’t take it." He added that "All pregnant women should talk to their doctors for more information about limiting the use of this medication while pregnant." He acknowledged that a fever during pregnancy sometimes requires treatment, but urged mothers to use Tylenol only when necessary and at the lowest effective dose.

Trump said the FDA's labeling change will be "effective immediately" and that doctors would receive a formal notice warning against uses that could increase risk. The White House cited studies from Johns Hopkins that found "consistent associations between acetaminophen in pregnancy and autism," and noted a Nurses’ Health Study run with researchers from Yale, Columbia and Harvard that looked at about 9,000 children and found an association with neurodevelopmental disorders. A Mount Sinai–Harvard review of existing literature described an "overwhelming" amount of evidence pointing to an association.

Beyond the Tylenol warning, Trump also cast doubt on the nation’s vaccine schedule, saying, "You have a little child, little fragile child, and you get a vat of 80 different vaccines, I guess, 80 different blends, and they pump it in. So ideally, a woman won’t take Tylenol, and on the vaccines, it would be good instead of one visit where they pump the baby, you load it up with stuff, you do it over a period of four times or five times."

Officials did not immediately release independent corroboration or reaction from the broader medical community. The White House described the Tylenol-label update as part of a broader effort to examine potential environmental and developmental factors involved in autism and other neurodevelopmental conditions. The FDA’s labeling changes are expected to be implemented in the coming weeks, with doctors notified directly about the guidance.

This is a developing story. Check back for updates.