The Trump administration plans to announce on Monday that pregnant women's use of Tylenol may be linked to autism, according to reports.
Four sources familiar with the matter indicate that federal health officials are expected to advise pregnant women to avoid taking Tylenol during early pregnancy unless they have a fever. Officials will also highlight a folic acid medication called "leucovorin" as a potential autism treatment drug.
The U.S. Department of Health and Human Services (HHS) and the White House have not immediately responded to requests for comment.
President Trump announced on Saturday that his administration would make an autism-related announcement on Monday.
"I think this will be an extremely important announcement," Trump said during remarks at an event hosted by the America First Policy Institute. "I believe this will be one of the most important things we're going to do."
Earlier this month, reports emerged that HHS Secretary Kennedy was preparing to release a report linking prenatal use of acetaminophen (Tylenol's generic name) to autism. Following these reports, shares of Tylenol manufacturer Kenvue declined significantly.
A Kenvue spokesperson stated: "Rigorous research recognized by leading medical professionals and global health regulatory agencies over more than a decade has shown there is currently no reliable evidence proving a connection between acetaminophen and autism."
The spokesperson added: "We believe independent, reliable scientific research has clearly demonstrated that taking acetaminophen does not cause autism. We strongly oppose any claims to the contrary and are deeply concerned about the health risks such claims pose to expectant mothers."
Tylenol has added a "Recent Media Reports Statement" section to its official website, clearly stating that "there is currently no evidence proving a connection between taking acetaminophen and autism."
Earlier this month, Kenvue CEO Kirk Perry met with Kennedy to emphasize the above scientific conclusions and attempted to dissuade Kennedy from listing Tylenol as a potential cause of autism in his upcoming autism-related report.
Kenvue executives indicated that there are virtually no safe alternatives to acetaminophen for treating fever in pregnant women.
The U.S. Food and Drug Administration (FDA) and major medical organizations have consistently considered acetaminophen safe for pregnant women when taken as directed by healthcare providers, while recommending that anyone should consult healthcare providers before taking over-the-counter medications.
Kennedy has made autism a core focus of HHS work, promising to "thoroughly investigate" the causes of this neurodevelopmental disorder. In the past, he has made unfounded statements about autism prevalence and causes.