The U.S. Department of Health and Human Services will reportedly point to Tylenol use during pregnancy as a potential cause of autism in a forthcoming report on what’s driving rising rates of the developmental disorder.
In addition, the report is expected to suggest that low levels of folate, among other factors, may play a role and that a form of folate known as folinic acid, or leucovorin, could lessen symptoms of autism, according to The Wall Street Journal.
The news comes little more than a week after Secretary of Health and Human Services Robert F. Kennedy Jr. told President Donald Trump that he would have “announcements” on autism soon. Kennedy had promised in April to “know what has caused the autism epidemic” by this month.
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“We’re finding interventions, certain interventions now that are clearly almost certainly causing autism and we’re gonna be able to address those in September,” Kennedy said during a cabinet meeting in late August.
The report, which is being prepared by the National Institutes of Health, is expected to be a review of existing research that includes possible causes of autism and a rundown of what is known and unknown, The Wall Street Journal said.
Kennedy has spent years promoting a link between autism and vaccines despite numerous studies discrediting that theory. It is unclear if vaccines will be mentioned in the HHS report.
“We are using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates. Until we release the final report, any claims about its contents are nothing more than speculation,” an HHS spokesperson told Disability Scoop on Friday.
Kennedy’s effort to uncover the cause of autism has been met with skepticism from many researchers in the field who say that increased prevalence rates are largely due to better awareness, improved screening tools and methods and changes to the diagnostic criteria.
The Autism Science Foundation said that autism results from a mix of genetic and environmental factors with genetics playing the largest role.
“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,” said Dr. Alycia Halladay, the group’s chief science officer.
An analysis published in August in the journal BMC Environmental Health looking at 46 studies found an association between prenatal exposure to acetaminophen, which is sold under the brand name Tylenol, and an increased risk of neurodevelopmental disorders including autism. But, Dr. Diddier Prada of the Icahn School of Medicine at Mount Sinai who led the study emphasized that this association does not equal causation.
“We cannot answer the question about causation — that is very important to clarify,” Prada told The New York Times, offering an analogy. “Ice cream sales go up in the summer and also violent crime increases during summer — these are associated, but it doesn’t mean that the ice cream is causing violent crime.”
The Autism Science Foundation noted that one of the studies included in the analysis relied on siblings as controls, mitigating some maternal health factors and genetic influences. In this case, no association between acetaminophen and autism was found. The group said those same findings were replicated in a recent study from Japan that looked at siblings, which was not included in the review.
“Any association between acetaminophen and autism is based on limited, conflicting and inconsistent science and is premature given the current science,” according to the nonprofit.
That sentiment was echoed by Dr. Christopher Zahn, chief of clinical practice at the American College of Obstetricians and Gynecologists.
“There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” Zahn said. “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief. ACOG’s clinical guidance remains the same and, as always, any medication taken during pregnancy should be used only as needed, in moderation and after the pregnant patient has consulted with their doctor.”
Kenvue, which makes Tylenol, said that acetaminophen is one of the most studied medications in history.
“Nothing is more important to us than the health and safety of the people who use our products. We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism,” the company said in a statement. “To date, the U.S. Food and Drug Administration (FDA) and leading medical organizations agree on the safety of acetaminophen, its use during pregnancy, and the information provided on the label.”
