US Health Department plans to tie Tylenol to autism risk
Federal health officials are set to unveil research on autism's causes and therapies, tying its prevalence to the use of acetaminophen.
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US Health Secretary Robert F. Kennedy Jr. attends a news conference, Tuesday, August 5, 2025, in Anchorage, Alaska. (AP)
The Trump administration is preparing to announce new initiatives Monday that officials say could reshape the understanding and treatment of autism, The Washington Post reported, citing four people familiar with the plans who spoke on the condition of anonymity because details have not yet been made public.
Federal health officials are expected to caution against the use of acetaminophen, the active ingredient in Tylenol and one of the world’s most widely used medications, during early pregnancy.
The move follows a review of existing research, including an August study by Mount Sinai and Harvard scientists, that suggested a potential association between prenatal acetaminophen exposure and a heightened risk of autism in children. Officials plan to recommend that pregnant women avoid Tylenol unless treating a fever, the individuals said.
In addition, the administration intends to highlight leucovorin, a lesser-known drug commonly used to offset the side effects of certain medications and to treat vitamin B9 deficiency, as a possible therapeutic drug against autism. Double-blind, placebo-controlled trials of leucovorin in children with autism have shown what researchers describe as striking improvements in communication skills. FDA officials have been reviewing proposed language that could apply to the drug.
The findings have stirred debate among scientists, reopening questions about the causes of autism, long thought by many researchers to be predominantly genetic, and whether the condition might be more treatable than previously assumed.
The initiative has been a personal priority for US President Donald Trump, who has repeatedly voiced concerns about rising autism diagnoses. He tasked senior officials with pursuing answers earlier this year, drawing in Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and other top aides.
'I think we found an answer to autism'
Trump previewed the move Sunday during a speech at Charlie Kirk’s memorial service in Arizona. “Tomorrow we’re going to have one of the biggest announcement[s] … medically, I think, in the history of our country,” he said. “I think you’re going to find it to be amazing. I think we found an answer to autism.”
Separately, the NIH is set to announce Monday the launch of its autism data science initiative, which will fund 13 research teams studying the condition’s causes and treatments. That effort, led by career scientists, is distinct from a broader NIH review of autism research, which is ongoing and not expected this week. Bhattacharya has told colleagues he wants the review to be exhaustive and not rushed to coincide with the White House announcement.
Administration officials have framed Monday’s developments as historic. “President Trump pledged to address America’s rising rate of autism, and to do so with Gold Standard Science,” White House spokesman Kush Desai said in a statement. “Tomorrow’s announcement will make historic progress on both commitments.”
Long-debunked theory linking vaccines to autism
The Wall Street Journal had previously reported that the administration was examining the role of Tylenol and leucovorin. Current guidelines from major medical societies continue to describe acetaminophen as safe for pregnant women, though they recommend consulting a physician before taking any medication during pregnancy.
Tylenol executives have met with administration officials in recent weeks to raise questions about the review and discuss next steps. The company did not immediately respond to a request for comment.
Kennedy, who has made autism central to his “Make America Healthy Again” agenda, has pushed aggressively for the initiative. At a televised Cabinet meeting in April, he said: “We’ve launched a massive testing and research effort that’s going to involve hundreds of scientists from around the world. By September, we will know what has caused the autism epidemic, and we’ll be able to eliminate those exposures.”
Those remarks alarmed many scientists, who stressed that autism research is complex and requires years to conduct responsibly. Since Kennedy assumed his Cabinet role, speculation has swirled that HHS might attempt to revive the long-debunked theory linking vaccines to autism, a position Kennedy has publicly promoted for years.
Under his leadership, HHS hired David Geier, a controversial figure who has claimed vaccines increase autism risk, to work on a federal study of the issue. Geier and his father, Mark Geier, have long published research asserting such a connection, despite decades of scientific evidence disproving it.
Autism spectrum disorder is a neurodevelopmental condition marked by social and communication challenges and repetitive behaviors. The CDC estimates that one in 31 US 8-year-olds has autism, compared with one in 150 in 2000. While increased testing and awareness account for part of the rise, many researchers believe additional genetic, environmental, and lifestyle factors are contributing. More than 100 genes have been associated with autism, but its precise causes remain unclear.