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Public health experts have strongly disputed Donald Trump’s claim that taking Tylenol during pregnancy is linked to autism.
The U.S. president and Health Secretary Robert F. Kennedy Jr. said on Monday that acetaminophen, the active ingredient in Tylenol, “can be associated with a very increased risk of autism.”
Trump told reporters at the White House that the Food and Drug Administration (FDA) would be notifying physicians and updating guidance.
- Public health experts strongly dispute Trump's claim linking prenatal Tylenol use to autism, citing a lack of credible scientific evidence.
- The FDA plans to update Tylenol labels following Trump's announcement, despite expert criticisms of the claim's validity.
- Leading obstetricians and maternal health groups warn that no reputable studies prove that acetaminophen causes autism or neurodevelopmental disorders.
- A major 2024 JAMA study and analysis of sibling data found no significant associations between prenatal acetaminophen use and autism or ADHD.
- Tylenol manufacturer Kenvue rejects the claim, emphasizing acetaminophen as the safest pain reliever during pregnancy and noting market value loss after the claim.
Health experts have disputed Donald Trump’s claim linking Tylenol to autism
Image credits: Tom Brenner for The Washington Post via Getty Images
There will also be label changes to Tylenol and other similar medications to reflect the claims.
“Taking Tylenol is not good,” Trump said. “For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.
“For instance, in cases of extremely high fever that you feel you can’t tough it out.”
Trump even claimed that there were parts of the world, such as Cuba, that have “virtually no autism” because they don’t have Tylenol, which is known as paracetamol in other countries.
The claims have been sharply criticized and highly disputed by medical experts, who say there is no credible link between Tylenol and autism.
President Trump: “Taking Tylenol is not good. Alright, I’ll say it. It’s not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.” pic.twitter.com/x44PfHPOlA
— CSPAN (@cspan) September 22, 2025
Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said the suggestion that acetaminophen use in pregnancy causes autism is concerning and irresponsible.
“Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children.
“It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.
“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children.
“In fact, the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.”
Image credits: Ute Grabowsky/Photothek via Getty Images
A study published in Environmental Health in August analyzed the data from 46 studies and claimed there was a connection between prenatal acetaminophen exposure and increased risks of autism and ADHD.
However, the study did not show that acetaminophen directly causes neurodevelopmental disorders, and researchers said they “cannot establish causation for any single exposure.”
Fleischman said studies showing a causal link between autism and Tylenol, including the one published in August, had methodological limitations, such as a lack of a control for confounding factors or the use of unreliable self-reported data.
Most scientists dispute a link between Tylenol and autism, and a prominent study published in the Journal of the American Medical Association (JAMA) in 2024 found no connection.
Experts say Tylenol remains the safest option during pregnancy
Image credits: Elisa Schu/picture alliance via Getty Images
Researchers analyzing siblings whose mother only took Tylenol in one pregnancy found “no evidence of increased risk of autism, ADHD, or intellectual disability associated with acetaminophen use.”
Trump and RFK Jr.’s claims have also been rejected by the Society for Maternal-Fetal Medicine (SMFM), which is continuing to recommend acetaminophen as an appropriate medication to treat pain and fever during pregnancy.
“Despite assertions to the contrary, a thorough review of existing research suggesting a potential link between acetaminophen use during pregnancy and an increased risk of autism and attention deficit and hyperactivity disorder (ADHD) in children has not established a causal relationship,” SMFM said in a statement.
“To be clear, SMFM stands behind our recommendation that acetaminophen use during pregnancy has not been shown to cause or increase the risk of autism or other neurobehavioral problems in children.
“SMFM supports continued research that includes pregnant patients to understand the potential causes of neurodevelopmental disabilities in children.”
Image credits: Justin Sullivan/Getty Images
Professor Claire Anderson, president of the Royal Pharmaceutical Society, said paracetamol had been used safely for decades and it remains a safe option.
“Paracetamol has been used safely by millions of people for decades, including during pregnancy, when taken as directed. It is the first-line choice for pain management and fever control in a variety of patients, including pregnant women, children and the elderly,” she said.
Anderson also referenced the JAMA study published in 2024, saying, “This research, which followed over 2.4 million children, provides reassurance for expectant parents that paracetamol remains a safe option for managing pain or fever during pregnancy when used as recommended.
“Anyone with concerns about their medicines should speak to a pharmacist or other trusted healthcare professional to ensure they are getting sound advice from a trusted source.”
RFK Jr. has previously come under fire for his views and approach to autism.
RFK Jr.’s views are widely seen as controversial
Image credits: Win McNamee/Getty Images
Earlier this year, he was sharply criticized for announcing plans to build an autism registry in the U.S. using the private health care data of Americans.
He has also previously suggested there is a link between vaccines and autism, when there is no scientific evidence to corroborate this.
In April, RFK Jr. also set himself a deadline to find the cause of autism and announced he would have definitive answers by September.
At the press conference on Monday, it was also announced that the FDA will soon approve a new drug to treat autism in children.
Leucovorin, also known as folic acid, will be used to treat autistic children deficient in folate, a form of vitamin B.
Image credits: Andrew Harnik/Getty Images
FDA Commissioner Dr. Marty Makary claimed it could help improve verbal communication.
However, health experts have cautioned that more evidence is needed on the effects of Leucovorin and core autistic traits.
“Any evidence available at this point is exceptionally tentative and would not be considered to be robust,” Dr. Monique Botha, associate professor in social and developmental psychology at Durham University, said.
“Similarly, whilst medications may help with very specific aspects, there is no medication or treatment that actively cures or erases autism, though it might adjust behavior, or reduce co-occurring symptoms which contribute towards distress for autistic people.
“Autism is a lifelong heritable disability whose primary cause is exceedingly likely to be genetic, expressed through a wide array of genes. Similarly, autistic people are exceptionally heterogenous so any treatment or medication for specific traits is likely to work for very specific presentations of autistic traits, in very particular contexts.”
Image credits: Andrew Harnik/Getty Images
“Sweeping statements about cures or treatments do not tend to be accurate, helpful, or ethical,” Botha added.
The makers of Tylenol, Kenvue, have also released a statement disputing assertions made by Trump and RFK Jr.
Shares of Kenvue tumbled to a record low on Monday after reports circulated that Trump was planning to link Tylenol to autism, erasing an estimated $2.6 billion in market value, with shares falling 7.5%.
“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,” a Kenvue spokesperson 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,” they added.
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