The White House is expected make an announcement Monday on its efforts to identify the cause of autism and reportedly will link the neurological condition to the common over-the-counter pain reliever acetaminophen.
According to multiple reports, the announcement is expected to link the development of autism to pregnant women’s use of acetaminophen, the primary ingredient in Tylenol.
Pregnant women already have few safe options for pain relief, and an announcement touting a link to autism could put them in a difficult position. Ibuprofen and the brand-name Advil are already discouraged due to the risks of miscarriage and birth defects.
The American College of Obstetricians and Gynecologists (ACOG) said in a statement that “acetaminophen remains a safe, trusted option for pain relief during pregnancy.”
“Despite recent unfounded claims, there’s no clear evidence linking prudent use to issues with fetal development,” it added.
President Trump previewed the announcement, expected during a 4 p.m. EST event on Monday, at Sunday’s memorial service for Charlie Kirk.
“I think you’re going to find it to be amazing,” Trump said. “I think we found an answer to autism.” He didn’t provide other details, adding only that he expects it to be “one of the most important news conferences I’ll ever have.”
Efforts to identify the cause of autism have been a top priority for Trump, who tasked top health officials with finding an answer. Health and Human Services Secretary Robert F. Kennedy Jr. vowed to unveil the cause of the “autism epidemic” by September of this year.
The Wall Street Journal first reported earlier this month that Kennedy planned to release a report linking autism and the use of acetaminophen during pregnancy.
Additionally, the White House will reportedly recommend the use of a medication known as leucovorin to decrease symptoms of autism. Leucovorin is a form of folic acid, an essential B vitamin.
Major medical societies, including the Society of Maternal Fetal Medicine (SMFM), advise that acetaminophen is safe to use, though they also recommend speaking with their health providers before taking it.
“At this time, the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive,” SMFM President Sindhu Srinivas said.
Tylenol manufacturer Kenvue in a statement strongly disputed any link between acetaminophen use during pregnancy and autism.
“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 said in a statement.
“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.”
The company said executives had “engaged in a scientific exchange” with Kennedy and members of his staff, after the Wall Street Journal reported Kenvue’s CEO met with Kennedy to lobby him against making the announcement.
The interest in acetaminophen was spurred by a recently published National Institutes of Health-funded study. The researchers said their analyses of previous studies “support evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence” of neurodevelopmental disorders.
However, experts say the study was flawed, did not show causation, and was not sufficient grounds for changing medical recommendations.
Diddier Prada, a researcher at Icahn School of Medicine at Mount Sinai, which led the study, stressed that the findings do not prove a causal link.
“We show that acetaminophen is associated with a higher risk, but not causing it. Those are very different things,” he said in an interview with The Washington Post.
The current understanding of the cause of autism is brought on through a combination of genetic and environmental factors.
Kennedy has repeatedly pointed to the rising rate of autism diagnoses as proof of there being an artificial cause. He has long speculated on the mercury-containing vaccine preservative thimerosal and its potential links to autism, despite analyses repeatedly failing to find an association.
But experts say this is more likely due to improved detection since the first person was formally diagnosed with autism in 1943.
“It is disingenuous and misleading to boil autism’s causes down to one simple thing. We know that autism is incredibly complicated, and we need to move away from studies that simplify it down to one exposure without any other considerations”, Alycia Halladay, Chief Science Officer at the Autism Science Foundation, said in a statement.
According to experts, there is no new high-quality data warranting a review of the effects of acetaminophen. Those familiar with the matter who spoke with the Journal said Kennedy’s report will rely on existing research.
“Acetaminophen has been considered the safest and lowest risk medication … for pregnant people, for pain and fever. And importantly, there has not been any new major prospective, gold standard scientific studies that have come out to challenge this,” Lisa Zuckerwise, director of the Maternal-Fetal Medicine Program at UVA Health, told The Hill.
Heidi Leftwich is associate fellowship director for maternal-fetal medicine at the University of Massachusetts. Speaking with The Hill, Leftwich emphasized the critical importance of conducting thorough reviews of existing scientific literature before making broad recommendations that may dissuade people from taking certain medicines.
Leftwich noted that sibling studies have not found a link between acetaminophen and autism, ADHD or intellectual disability.
“Studies that have looked at the sibling effect have not actually shown the same association with Tylenol and the association with autism, I think that gives you pause, and I also think when there’s multiple studies that conclude different things,” said Leftwich.
“We need to look back at the methodology of the research that’s there, and we need to look at it carefully, and we need to be able to make a conclusion that we feel safe and thoughtful about.”
Alejandra O’Connell-Domenech contributed.
