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President Donald Trump on Monday announced that the Food and Drug Administration has approved leucovorin, a chemotherapy support drug, as a treatment for autism symptoms — and simultaneously issued a warning to doctors against recommending acetaminophen during pregnancy, citing concerns it may be linked to autism in children.
The dual announcement drew immediate pushback from medical experts, who say there is little scientific evidence supporting either claim.
Flanked at the White House by Health Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and CMS chief Mehmet Oz, Trump said his administration was committed to “finding the cause of autism” by the end of September.
“Taking Tylenol is not good. I’ll say it. It’s not good,” Trump told reporters, calling the policy shift a “breakthrough” in protecting children’s health.
FDA label change for leucovorin
Leucovorin, a form of folinic acid long used to offset the harsh side effects of chemotherapy, has also been tested off-label for children with autism. Some clinical trials have shown modest improvements in speech, but mainstream autism researchers caution that more evidence is needed.
Trump said the FDA updated leucovorin’s label Monday to list autism as an approved indication. Oz added that Medicaid will cover the treatment, predicting that private insurers will “rapidly follow.”
Warning against Tylenol use in pregnancy
Kennedy said the FDA would issue a “Dear Doctor” letter warning that acetaminophen — the active ingredient in Tylenol and one of the most widely used painkillers — should only be used during pregnancy to treat high fever. He also said the FDA would begin steps toward a formal label change.
Acetaminophen has been used safely by millions since the 1950s. The American College of Obstetricians and Gynecologists and other medical groups say it remains one of the only safe options for pain relief during pregnancy.
Scientists question evidence
Autism researchers rejected the administration’s framing. Dr. Allison Bryant, a high-risk obstetrician at Massachusetts General Hospital, said the Tylenol-autism theory “bubbles up every now and again” but has never been backed by conclusive science.
Brian K. Lee, an epidemiologist at Drexel University, said a major Swedish study of 2.4 million children found no link between acetaminophen use in pregnancy and autism, ADHD or intellectual disability. “The biggest elephant in the room here is genetics,” Lee said.
The Autism Science Foundation also emphasized that leucovorin is not yet considered a proven treatment, despite FDA’s move.
A spokesperson for Kenvue, which makes Tylenol, called the administration’s conclusions “misleading” and said acetaminophen remains “the safest option for pregnant women.”
A politically charged rollout
The Trump administration had been preparing to release a broader report on autism causes later this month. But Trump preempted the schedule over the weekend, teasing a “major breakthrough” before unveiling Monday’s announcement.
White House press secretary Karoline Leavitt urged reporters to approach the announcement with “critical thinking skills and open ears,” saying Trump and his team were “looking at gold-standard studies that others in Washington ignored.”
Still, outside researchers argue the administration’s interpretation of the science is selective. “The science hasn’t changed,” Lee said. “They are coming to a very different conclusion than many scientists would.”
