President Trump announced Monday what he described as a breakthrough in understanding autism, linking prenatal use of acetaminophen—commonly sold as Tylenol—to an increased risk of the disorder. The administration said new data compelled the Food and Drug Administration (FDA) to recommend that doctors caution pregnant women about the drug and prepare new warning labels.
Standing alongside Health and Human Services Secretary Robert F. Kennedy Jr., Trump said, “Tylenol taken during pregnancy can be associated with a very increased risk of autism.” He called the development part of “historic steps to confront the crisis of autism” and urged women to limit use unless medically necessary.
According to the White House, the findings draw on major studies, including the Boston Birth Cohort, the Nurses’ Health Study, and research by the Mount Sinai–Harvard collaborative. FDA Commissioner Marty Makary stated the evidence was strong enough that “we cannot ignore it.” Administration officials said the agency will move to update acetaminophen safety warnings for pregnant women.
The drug’s manufacturer, Kenvue, strongly rejected the claim, saying sound science shows acetaminophen does not cause autism. Leading medical experts also cautioned that while some research suggests a correlation between Tylenol use and autism diagnoses, causation has not been proven. They warned against overreaction, stressing that acetaminophen remains widely used as one of the safer options to treat fever and pain in pregnancy when taken as directed.
The announcement signals a dramatic policy shift and could reshape medical guidance, pharmaceutical labeling, and even potential litigation.