US President Donald Trump has urged pregnant women to avoid using Tylenol, citing an unproven connection between the common painkiller and autism.
The announcement came on Monday from the Oval Office, where Trump spoke alongside Health Secretary Robert F. Kennedy Jr., emphasizing caution when using acetaminophen, the main ingredient in Tylenol.
Trump said taking the drug during pregnancy "is no good" and recommended it only in cases of extreme fever. He linked the medication to autism, though scientific studies on this connection remain inconsistent and inconclusive.
Tylenol manufacturer Kenvue defended the safety of its product, stating in a BBC interview: "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 expecting mothers."
The company added that acetaminophen is the safest option for pain relief during pregnancy, warning that without it, women may face the difficult choice between enduring conditions like fever or using less proven alternatives.
During the announcement, Kennedy said the Food and Drug Administration (FDA) would soon issue guidance to physicians about the potential risks of taking Tylenol while pregnant.
He also revealed plans to update the drug’s safety label and launch a public awareness campaign.
The American College of Obstetricians and Gynecologists cautioned that the announcement "is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children."
Kennedy further stated that the FDA would approve Leucovorin, a drug used in chemotherapy, as a treatment for children with autism, citing research suggesting it may help children with folate deficiencies improve verbal communication.
Earlier this year, Kennedy promised "a massive testing and research effort" to explore the causes of autism within five months. Trump described the rise in autism cases as a "horrible crisis" and said he has "very strong feelings about" the issue.
Experts have warned that autism is a complex syndrome with no single cause, believed to arise from a mix of genetic and environmental factors.
While some studies suggest a possible link between Tylenol use during pregnancy and neurodevelopmental disorders, others, including a 2024 study of 2.4 million Swedish children, found no connection to autism, ADHD, or intellectual disabilities.
"There is no robust evidence or convincing studies to suggest there is any causal relationship," said Monique Botha, a professor of social and developmental psychology at Durham University. She noted that pain relief options for pregnant women are very limited, with Tylenol being one of the safest choices.
Autism diagnoses have risen sharply since 2000, reaching 2.77% among 8-year-olds by 2020, according to the US Centers for Disease Control and Prevention.
Researchers say the increase is partly due to greater awareness and broader diagnostic criteria, alongside ongoing studies of environmental influences.