U.S. President Donald Trump is expected to announce a link between pregnant people taking acetaminophen — the active ingredient in Tylenol — and autism, American news outlets report.
But medical experts, Tylenol’s owner and Trump’s own Food and Drug Administration (FDA) have maintained that the drug, used to relieve pain and fever, is generally safe to take while pregnant.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” a spokesperson for Tylenol’s owner, Kenvue, told the Star over email. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
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Here’s what we know so far.
Trump to link Tylenol to autism
On Monday, Trump officials are expected to announce that acetaminophen usage during pregnancy may increase the risk of autism in children, sources with knowledge of the decision told the Ìý²¹²Ô»åÌý.
The announcement is also expected to highlight leucovorin, a medication used to treat anemia and the side effects of certain drugs and chemotherapies, as a potential treatment for people with autism.
Trump hinted at the announcement during a memorial for slain conservative activist Charlie Kirk on Sunday, promising reporters that Monday’s announcement will be one of the biggest, medically, “in the history of our country.”
“I think you’re going to find it to be amazing,” he said. “I think we found an answer to autism.”
Earlier this month, Â that Health Secretary Robert F. Kennedy Jr. planned to link autism with Tylenol usage during pregnancy, alongside low levels of the vitamin folate, in an upcoming report.
Kennedy’s Department of Health and Human Services (HHS) also planned to spotlight leucovorin as a way to decrease the symptoms of autism, according to the Journal.
The HHS did not immediately respond to the Star’s requests for comment.
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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.
Organizations like the Society of Obstetricians and Gynaecologists of Canada (SOGC) agreed, : “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.”
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.
“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,” Kenvue said. “We stand with the many public health and medical professionals who have reviewed this science and agree.”
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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.
Meanwhile, Kennedy, who has blamed vaccines for the rise in autism despite a lack of research, promised to determine the cause of autism by September.
But brain experts say there is no single cause for autism, adding that the rhetoric appears to ignore decades of science into the genetic and environmental factors behind the disorder.
With files from the Associated Press