Trump Claims Tylenol Causes Autism When Taken Early in Pregnancy. Here’s What Experts Say

At a press conference on Sept. 22, Trump announced that “effective immediately,” the FDA will inform doctors that using acetaminophen during pregnancy “can be associated with a very increased risk of autism.”

Researchers have studied the possible link between acetaminophen and autism for years, but most findings have been inconclusive. Tylenol is also widely considered one of the safer options for treating pain or fever during pregnancy.

Tylenol’s parent company, Kenvue, told PEOPLE in a statement: “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 with the health risk this poses for expectant mothers.”

Many medical experts share that view.

“People have been taking Tylenol since 1960, and there’s a very long history of safety here,” said Dr. Karam Radwan, Director of the UChicago Medicine Neurodevelopmental Clinic.

Trump’s remarks were influenced by a study published in Environmental Health in August. That research reviewed data from several studies and suggested a “positive association” between prenatal exposure to acetaminophen — the active ingredient in Tylenol — and developmental conditions like autism. However, the authors stressed that they “cannot establish causation for any single exposure.”

Radwan explained that if a pregnant woman is using Tylenol frequently, it may be due to another health problem, such as infection, inflammation, or an autoimmune condition. Those conditions themselves, rather than Tylenol, could influence autism risk.

“That doesn’t mean Tylenol is the cause,” Radwan said. “The cause could be the reason why you’re taking Tylenol.”

He also urged mothers not to blame themselves. “I want to make sure that all the mothers who have kids with autism don’t blame themselves for taking Tylenol during pregnancy. I don’t think that’s a source of causality,” he said.

Radwan added that Tylenol’s safety record remains strong: “People have been taking Tylenol since 1960. The safety profile for Tylenol is impressive. There are very few medicines with a safety profile like that.”

The study’s authors also noted that untreated pain or fever in pregnancy can harm the baby. “Our study highlights the importance of discussing the safest approach with health care providers and considering non-drug options whenever possible,” said Dr. Diddier Prada of Mount Sinai’s Icahn School of Medicine, in a press release.

While the link between medications during pregnancy and developmental disorders continues to be studied, most scientists agree that autism does not have a single cause. Genetics, pregnancy complications, and environmental exposures can all play a role.

Kennedy, who had set a September deadline for identifying a cause of autism, has drawn criticism for his approach. He previously said people with autism will “never pay taxes. They’ll never hold a job. They’ll never play baseball.” He has also promoted the debunked claim that vaccines cause autism. Kennedy has announced plans to create a national registry of people with autism, using private medical records.

Other studies contradict the claim that Tylenol causes autism. For example, research published in the Journal of the American Medical Association found no link between acetaminophen use during pregnancy and autism, ADHD, or intellectual disability when studying siblings. The authors suggested that earlier findings may have been influenced by family-related factors.

Doctors do advise against overusing acetaminophen. “I will continue to say that Tylenol is pretty safe to use, but remind people — don’t take Tylenol unless you really need it,” Radwan said. “Like if you have a fever or severe pain that you can’t tolerate. You don’t want to take something more than you should.”

In another statement to PEOPLE, Kenvue said: “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. 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.”

The American College of Obstetricians and Gynecologists (ACOG) also defended the medicine’s use.

“Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” said Dr. Steven J. Fleischman, ACOG’s president, in a statement.