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The president also rehashed debunked claims that vaccines are linked to autism, telling reporters: “There are certain groups of people that don’t take vaccines and don’t take any pills that have no autism... The Amish as an example, they have essentially no autism.”

But medical experts and Tylenol’s owner have expressed doubts about Trump’s claims, noting a lack of compelling evidence linking autism with acetaminophen.

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” a spokesperson for Tylenol’s owner, Kenvue, said in an email. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”

Here’s what we know so far.

Trump links Tylenol to autism

Standing beside Trump, U.S. Health Secretary Robert F. Kennedy Jr. announced the FDA will issue a physician’s notice about the use of acetaminophen during pregnancy, and begin the process of issuing a safety label change for the drug.

Kennedy noted the FDA recognizes acetaminophen as one of the only tools to treat fevers and pain in pregnancy, noting that “other alternatives have well-documented adverse effects.” But he advised clinicians to only prescribe the “lowest effective dose for the shortest necessary duration, and only when treatment is required.”

“You know the way I look at it? Don’t take it. Don’t take it! There’s no downside in not taking (Tylenol),” Trump added. “There’s a rumour... that Cuba, they don’t have Tylenol because they don’t have the money for Tylenol, and they have virtually no autism.”

The HHS and FDA did not immediately respond to the Star’s requests for comment.

Kennedy also spotlighted leucovorin, a medication used to treat anemia and the side effects of certain drugs and chemotherapies, as a potential treatment for people with autism. In this regard, FDA Commissioner Dr. Marty Makary announced his agency will change the label on leucovorin to make it available to children with autism starting Monday.

“Hundreds of thousands of kids, in my opinion, will benefit,” Makary said.

Kennedy said he also directed his Department of Health and Human Services to launch an “unprecedented, all-agency effort to identify all causes of autism.” He previously promised to determine the cause of autism by September.

The director of the U.S. National Institutes of Health, Dr. Jayanta Bhattacharya, also announced a new initiative to “turbocharge” autism research, earmarking $50 million to support 13 projects investigating the root causes of and therapies to treat autism.

Does Tylenol actually cause autism?

Trump’s announcement follows recent research associating prenatal acetaminophen usage with neurodevelopmental diseases like autism — co-authored by the dean of Harvard’s T.H. Chan School of Public Health, Dr. Andrea Baccarelli.

“There was strong evidence of a relationship between prenatal acetaminophen use and increased risk of (autism spectrum disorder) in children,” the review read. “Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.”

But other research, such as a, found no such relationship . Some experts have also expressed doubts: “Regarding Tylenol in pregnancy, this is rushed science and not yet born out in the data,” said Dr. Stephen Scherer, Chief of Research at SickKids Research Institute and an expert on autism spectrum disorders.

“It’s not based on science, and it’s doing a disservice to pregnant individuals out there and people who have kids with autism,” added Dr. Graeme Smith, editor-in-chief of the Journal of Obstetrics and Gynaecology Canada. “I think that there’s a real potential to cause harm both for pregnant individuals but also for people who’ve got kids with autism.”

Organizations like the Society of Obstetricians and Gynaecologists of Canada (SOGC) have also cast doubt on the data, : “Despite some claims suggesting a causal link between prenatal exposure to acetaminophen and certain neurodevelopmental disorders ... the evidence supporting these claims is weak and has been consistently refuted by scientific and regulatory bodies.”

In a , the SOGC recommended taking acetaminophen as a “first-line therapeutic option for fever and pain in pregnancy when medically indicated at recommended doses for the shortest duration required.”

As of Monday morning, the FDA webpage for acetaminophen, which was updated the day Baccarelli’s review was published, said it “has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.” The FDA recommends consulting a health care professional before taking any medication, including acetaminophen, during pregnancy.

“acetaminophen is safe and effective when used as directed,” although misuse may lead to liver damage.

“We know that the cause of autism or ADHD is multifactorial but genetics seems to play a significant component of it,” Smith said. “So trying to point a finger at one thing that somebody took during pregnancy is just not going to show true cause and effect.”

What is leucovorin, and can it treat autism?

Leucovorin, or folinic acid, is a drug currently used to treat anemia and the side effects of certain drugs. suggests its usage may also help improve some autism symptoms in children.

I, researchers linked a deficiency in folate to autism-like symptoms in children. found about two-thirds of children who took leucovorin, which is a form of folate, experienced improvements in “verbal communication, receptive and expressive language, attention and stereotypical behaviour.”

In the last five years, randomized control trials in countries including , , and have reached similar conclusions.

No serious adverse effects have yet been reported.

Autism rates have risen sharply in the last two decades, . In the year 2000, about one in 150 children were diagnosed with autism. As of 2022, the rate has risen to one in 31 children — although scientists have attributed this surge, at least in part, to better awareness and an expanded definition of autism spectrum disorder.

With files from the Associated Press