Trump calls for limiting Tylenol use in pregnant women due to possible autism risk

President Donald Trump, Health Secretary Robert F. Kennedy Jr. and other top health officials said Monday that the popular analgesic Tylenol may be linked to an increased risk of autism when used during pregnancy.

"They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary," Trump said, announcing that his administration will implement measures to reduce the risks. The president added: "Ideally, you don’t take it at all, but if you have to, you can’t tough it out … probably, you’re going to end up doing it."

White House action plan

The White House presented an action plan on autism with three main thrusts. First, the Food and Drug Administration (FDA) will issue a notice to physicians and initiate a change in the safety labeling of acetaminophen, after research showed a possible association between its use during pregnancy and adverse neurodevelopmental outcomes, recommending cautious use in pregnant women, infants and young children. At the same time, the Department of Health and Human Services (HHS) will launch a national public service campaign to inform families and protect public health. Second, the FDA will act to establish leucovorin as the first recognized treatment for children with brain folate deficiency and autistic symptoms, allowing state Medicaid programs to cover this drug for autism spectrum disorder, while the National Institutes of Health (NIH) will launch confirmatory trials and new research on its impact. Finally, the plan calls for increased investment in research, and through the Autism Data Science Initiative (ADSI), the NIH will fund thirteen projects with an investment of more than $50 million to transform studies in the field.

"We expect this to be the first of MANY announcements over the coming years that deliver actionable information to parents on underlying causes of autism and the potential paths for prevention and reversal," Kennedy Jr. said.

The secretary had already assured earlier this year that he would provide news this month on one of his major goals: identifying the causes of the autism "epidemic."

The anticipated announcement was leaked to the press by members of the administration days before the secretary spoke, leading to a drop in the stock of the company behind the brand, Kenvue.

Industry reaction

Senior executives at the company reportedly tried to persuade HHS to exclude its products from the autism report. In an email picked up by Reuters, the company acknowledged this back-and-forth: "As we would with any regulator who reaches out to us, we engaged in a scientific exchange with the secretary and members of his staff as it relates to the safety of our products."

According to the same agency, Kenvue maintained that it continues to believe that Tylenol does not cause autism. In another statement, this one to POLITICO, the company argued that discouraging consumption of its drugs would force pregnant women to make "dangerous choices": enduring pain that could be dangerous for her or the baby or taking riskier painkillers.

In response to media anticipation, the company also opened a section on the FAQ tab of its official site, assuring that "Credible, independent scientific data continues to show no proven link between taking acetaminophen and autism."

"Our best advice? Talk to your healthcare professional before taking or administering acetaminophen," it recommends after citing medical organizations that agree with their assertion, such as the American College of Obstetricians and Gynecologists and (at least for now) the FDA.

"If you are treating your little one with acetaminophen, please know that there is no credible science that shows taking acetaminophen causes autism," it also states.