President Donald Trump announced that the Food and Drug Administration is issuing a physician notice and beginning the process for updating safety labels for acetaminophen, linking its use during pregnancy to autism — despite disputed science.
The administration said research suggests a possible association between acetaminophen, the active ingredient in Tylenol, and adverse neurodevelopmental outcomes.
"Don't take Tylenol if you're pregnant and don't give Tylenol to your child when he's born," President Trump said.
Despite Trump's insistence that pregnant women should not take acetaminophen, the official guidance from his administration is for clinicians to "exercise their best judgment" when recommending the drug for fevers and pain during pregnancy.
The FDA also notes that "acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children."
Even so, Trump went on to cite anecdotal evidence, bringing up the Amish community and claiming very few members are diagnosed with autism.
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"The Amish, virtually, I heard none," President Trump said as he turned to Health and Human Services Secretary Robert F. Kennedy Jr. "You see, Bobby wants to be very careful with what he says, and he should, but I'm not so careful with what I say."
Kennedy, a longtime critic of mainstream medical guidance, said autism was not the only concern with acetaminophen use.
"Thanks to the politicization of science, the safety of acetaminophen against the risk of neurodevelopmental disorders in young children has never been validated," he said. "Prudent medicine therefore suggests caution in acetaminophen use of young children, especially since strong evidence also has associated it with liver toxicity."
Medical experts and public health officials have cautioned against drawing causal links between over-the-counter medications and autism without substantial peer‑reviewed evidence.
“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children," said Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists. "In fact, the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.
The maker of Tylenol, Kenvue, said the company stands with public health officials and believes there's no credible evidence linking acetaminophen to autism.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents," Kenvue said in a statement. "The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism. We stand with the many public health and medical professionals who have reviewed this science and agree."
Tylenol also created an FAQ page to help patients navigate when Tylenol use is appropriate.
Autism Speaks, a nonprofit advocacy group, reports that one in 31 children in the U.S. has a form of autism, along with one in 45 adults.
"Women who are pregnant and families considering new therapies for autism should always consult with their doctor," the group said in a statement following Monday's announcement. "While some observational studies have suggested possible associations between Tylenol (also known as acetaminophen) and autism, it is important to note that they have not — to date — proven causation, which we know to be influenced by many other factors such as genetics, parental health and environment."
Meanwhile, for those with autism, the FDA on Monday it is initiating approval of leucovorin calcium tablets for patients with cerebral folate deficiency. The agency said individuals with the condition often experience developmental delays with autistic features.
