WASHINGTON — U.S. President Donald Trump on Monday said federal health officials will soon advise doctors not to prescribe the pain reliever Tylenol to pregnant women, citing disputed research that links the drug to autism.
Speaking in the Oval Office alongside Health Secretary Robert F. Kennedy Jr., Trump described the reported rise in autism cases as a “horrible crisis” and claimed acetaminophen — the active ingredient in Tylenol — “is no good” for expectant mothers except in cases of extreme fever.
Kennedy said the Food and Drug Administration (FDA) will issue new guidance warning physicians about potential risks and initiate steps to add a safety label to Tylenol.
He also announced plans for a public health campaign and said the agency will move to approve the decades-old drug Leucovorin, typically used in cancer treatment, as a potential therapy for children with autism.
The FDA’s commissioner, Dr. Marty Makary, said approval would be based on studies suggesting that Leucovorin, also known as folinic acid, may help autistic children with folate deficiencies improve verbal communication.
However, researchers caution the evidence remains preliminary, with only small-scale trials conducted so far.
Fierce medical pushback
The announcement has drawn swift criticism from leading medical groups, who argue the administration is overstating uncertain science and potentially endangering maternal health.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the move “dangerously simplifies the many and complex causes of neurologic challenges in children” and does not reflect the full body of research.
He noted that acetaminophen remains one of the few safe pain-relief options during pregnancy and is recommended by doctors worldwide.
Pharmaceutical giant Kenvue, which makes Tylenol, also rejected the White House’s claims.
“Independent, sound science clearly shows that taking acetaminophen does not cause autism,” the company said in a statement to the BBC, warning that discouraging its use could pose “serious health risks” to expectant mothers.
Conflicting science
Research into a potential link between acetaminophen and autism has produced mixed results.
Some studies have suggested a correlation, while others — including a massive 2024 study of 2.4 million Swedish children — found no evidence of increased autism risk.
The Autism Science Foundation notes that while low folate levels in early pregnancy have been associated with autism risk in some research, findings are inconsistent.
Trials exploring folinic acid as a treatment have shown some promise but remain too small to draw firm conclusions.
Autism rates in the United States have climbed sharply over the past two decades, now affecting nearly 3% of 8-year-olds, according to the Centers for Disease Control and Prevention.
Experts attribute the rise largely to broader diagnostic criteria and greater awareness, not a single cause.
“The truth is, there is no robust evidence linking acetaminophen to autism,” said Dr. Monique Botha, a developmental psychologist at Durham University. “What we do know is that pain relief for pregnant women is already woefully lacking.”
Political backdrop
Kennedy, a longtime critic of pharmaceutical companies, has previously promoted debunked theories linking vaccines to autism.
In April, he pledged to find the cause of autism within five months through “a massive testing and research effort.”
Trump has frequently spoken about autism during his presidency, often describing it as an “epidemic” despite scientists warning against such framing.
For now, many medical professionals say the administration’s move risks creating confusion among pregnant women, potentially leading them to avoid safe medication for conditions like fever — which itself can harm both mother and child.
