The FDA is notifying clinicians that Tylenol (acetaminophen) use during pregnancy can be associated with an increased risk of autism and attention-deficit/hyperactivity disorder; leading healthcare organizations say these claims are unfounded.
During a Sept. 22 press conference, President Donald Trump cited the CDC’s reports on the rate of autism diagnoses in the U.S. In April, a CDC study estimated that 1 in 31 U.S. children are diagnosed with autism before their 8th birthday. In 2016, the estimate was 1 in 54 8-year-olds, and in 2000, it was 1 in 150.
Researchers have hypothesized the rise in autism diagnoses are associated with environmental factors; increased advocacy and education; and new developmental screening practices, diagnosis definitions and policies. President Trump said the rise in prevalence is tied to Tylenol use during pregnancy.
“So taking Tylenol is not good. Alright, I’ll say it. It’s not good,” President Trump said, flanked by HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz, MD. “For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” such as cases of “extremely high fever.”
“Fight like hell not to take it,” he said later in the conference.
To reflect this claim, the FDA is updating acetaminophen safety labels and has initiated the approval of leucovorin calcium tablets for adults and children with cerebral folate deficiency, which the agency said is associated with autistic features. Leucovorin is currently approved to treat chemotherapy side effects.
The National Institutes of Health is also devoting $50 million to launch an Autism Data Science Initiative and fund 13 research projects to study autism.
“The FDA is responding to clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse developmental outcomes, including later diagnosis for ADHD and autism,” Mr. Kennedy said.
A 2024 study spanning more than 2 million children in Sweden found that the use of acetaminophen during pregnancy was not associated with a risk of a child developing autism, ADHD or intellectual disability.
The Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists said Sept. 22 acetaminophen is appropriate and safe to treat pain and fever during pregnancy.
Mr. Kennedy said the federal government is investigating multiple potential causes of autism, adding that a topic of concern is vaccines.
The press conference was rife with misinformation. President Trump said children receive 80 vaccines under current recommendations and suggested vaccines cause autism. A large body of scientific research refutes this claim, including 16 population-based studies across multiple countries that found no association between autism and several vaccines.
“There are certain groups of people that don’t take vaccines and don’t take any pills, that have no autism. That have no autism. Does that tell you something? That’s currently– is that a correct statement by the way?” President Trump said, turning to Mr. Kennedy, who said there are studies showing this trend among Amish people.
The president also said measles, mumps and rubella vaccines should be split into three separate vaccines. The week before, a CDC vaccine advisory panel voted to not recommend the quadrivalent MMR and varicella (chickenpox) vaccine for children younger than 4 years old.
