President Donald Trump announced Monday that he has directed the Food and Drug Administration (FDA) to issue new guidance advising against the use of Tylenol (acetaminophen) during pregnancy, citing a potential link to autism.
“So taking Tylenol is not good,” Trump said during a White House press briefing.
“I’ll say it. It’s not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.” He added that the FDA will begin notifying doctors that acetaminophen “can be associated” with an increased risk of autism and recommended that, “Ideally, you don’t take it at all.”
The warning is part of a broader push by the administration to address autism, an effort led by Health Secretary Robert F. Kennedy Jr. and supported by top health officials including FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz.
Trump, who had teased the announcement for days, appeared to preempt the release of a long-awaited federal report on autism causes, originally expected around September 29 or 30. During the briefing, he stated, “We understood a lot more than a lot of people who studied it,” speaking alongside Kennedy and other officials.
Also at Monday’s briefing, Kennedy said the FDA would issue a formal “Dear Doctor” letter advising health care providers to limit recommending acetaminophen during pregnancy, reserving its use for high fevers where the fetus could otherwise be at risk. He also said the FDA would begin the process of updating the safety labeling on acetaminophen products.
The move, however, contradicts long-standing guidance from the American College of Obstetricians and Gynecologists (ACOG), which continues to recommend acetaminophen as a generally safe option for managing pain and fever during pregnancy when used as directed.
At the same event, Trump also announced that the FDA had approved an update to the label of leucovorin, a chemotherapy drug sometimes used off-label to treat symptoms of autism, now officially recognizing its use in treating some autism-related symptoms. Leucovorin, a form of folinic acid (vitamin B9), has shown promise in early trials for improving speech in some children with autism. However, the Autism Science Foundation does not currently recommend it as a treatment, citing the need for more research.
CMS Administrator Mehmet Oz confirmed that Medicaid will begin covering leucovorin for autism treatment with a prescription and expressed confidence that private insurers would follow.
In addition, NIH Director Bhattacharya announced a new $50 million investment in 13 research projects as part of the “autism data science initiative,” which will explore a range of environmental, medical, nutritional, genetic, and prenatal factors to better understand autism’s root causes.
Despite the administration’s sweeping new proposals, many experts remain skeptical. Researchers with decades of experience in autism science said the administration has not presented any new evidence linking Tylenol or leucovorin to autism. Most scientists continue to emphasize that autism is a complex condition with multiple contributing factors, not a single, easily identifiable cause.
According to the Centers for Disease Control and Prevention (CDC), autism spectrum disorder affects approximately 1 in 31 children in the United States and is characterized by challenges in communication, social interaction, and repetitive behaviors.