Trump links autism to Tylenol ingredient acetaminophen during pregnancy

The Trump administration on Monday drew an unproven link between autism and pregnant women’s use of acetaminophen, the active ingredient in one of the world’s most common over-the-counter pain relievers, Kenvue‘s Tylenol.

President Donald Trump said the Food and Drug Administration will issue a physician’s notice about the risk of patients using acetaminophen during pregnancy unless they have a fever. The agency will also start the process of changing the safety label for acetaminophen on Tylenol and similar products.

The moves clash with a bulk of scientific literature suggesting no causal link between autism and exposure to acetaminophen in the womb. 

Many over-the-counter drugs contain acetaminophen, but Tylenol is widely considered the safest treatment to take during pregnancy to relieve pain and fever, as long as patients use the recommended dose. 

“Taking Tylenol is not good,” Trump said during a press conference on Monday. “They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary. That’s for instance, in cases of extremely high fever, that you feel you can’t tough it out, you can’t do it.”

The Health and Human Services Department will encourage clinicians to “exercise their best judgment” around the use of acetaminophen during pregnancy by “prescribing the lowest effective dose with the shortest necessary duration and only when treatment is required,” the department’s Secretary Robert F. Kennedy Jr. said during the press briefing.

HHS will launch a nationwide campaign to inform patients about the alleged risk, Kennedy said.

In a statement Monday, Kenvue said it believes in “independent, sound science” that shows taking acetaminophen does not cause autism, and “we strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.” Without the drug as an option, women may have to experience conditions like fever that are potentially harmful to both them and their babies, or use riskier alternatives, Kenvue said.

Untreated fever and pain during pregnancy can carry risks for both mother and infant, such as miscarriage, birth defects and high blood pressure, according to the Society for Maternal-Fetal Medicine.

FDA Commissioner Marty Makary suggested that treating a fever “can prolong the duration of illness in a young kid,” citing a study from Johns Hopkins, without further details.

“Maybe that’s because a fever is a body’s natural way of ridding an infection,” Makary said.

Trump, several times during the briefing, said “there’s no downside” to not taking Tylenol during pregnancy or in a baby’s early life.

The agency is specifically updating leucovorin’s label for cerebral folate deficiency, which HHS said has been associated with autism. The change will allow children with autism to be treated with the drug, with continued use if kids show language, social or adaptive gains, according to an HHS release.

But HHS said leucovorin is not a cure for autism and may only lead to improvements in speech-related deficits for a subset of children with the disorder. State Medicaid programs will be able to cover the drug for autism after the label update. The NIH will also start trials to confirm the effects of leucovorin on the disorder, including studies into the medicine’s safety.

While promising, it is important to note that leucovorin is not a cure for ASD and may only lead to improvements in speech-related deficits for a subset of children with ASD. Furthermore, this treatment must be administered under close medical supervision and in conjunction with other non-pharmacological approaches for children with ASD (e.g., behavioral therapy). 

Leucovorin is a form of folate, a B vitamin, that is typically prescribed to counteract some medications’ side effects, including chemotherapy, and to treat vitamin B9 deficiency. Some early placebo-controlled clinical trials have shown that oral leucovorin, also known as folinic acid, has the potential to improve symptoms in children with autism spectrum disorder.

The Food and Drug Administration early Monday published a notice saying it is approving a version of leucovorin that was previously made by GSK, the Wall Street Journal reported. But as of Monday afternoon, the Federal Register’s website said it has received an “agency letter” asking to withdraw the notice.

In a statement, a GSK spokesperson said it does not intend to market…