Upcoming HHS report will link autism to common pain reliever, folate deficiency in pregnancy, Wall Street Journal reports

By Brenda Goodman, Deidre McPhillips, CNN

(CNN) — An upcoming report from the US Department of Health and Human services is likely to link the development of autism in children to a common over-the-counter pain reliever, and it will reference a form of the vitamin folic acid as a way to reduce symptoms of autism in some people, the Wall Street Journal reported Friday.

The report is said to highlight the pain reliever Tylenol, when taken during pregnancy, along with low levels of folate, a vitamin that is important for proper development of a baby’s brain and spine, as potential causes of autism, according to the Wall Street Journal. It will also name folinic acid, a form of folate also known as leucovorin, as a way to decrease symptoms of autism.

Folate supplements are already recommended for women during pregnancy to prevent neural tube defects, such as spina bifida, in infants.

Tylenol, which is the brand name of the generic pain reliever acetaminophen, is widely used in the US, including during pregnancy. Drugmaker Kenvue said in a statement Friday, “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.”

Experts generally agree.

“There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” Dr. Christopher Zahn, chief of clinical practice for the American College of Obstetricians and Gynecologists, said in a statement Friday. “Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause. 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.”

The incidence of autism in the US is on the rise. About 1 in every 31 children was diagnosed with autism by age 8 in 2022, up from 1 in 36 in 2020, according to a US Centers for Disease Control and Prevention report published in April.

There are two primary reasons for the increase, according to Dr. Christine Ladd-Acosta, vice director of the Wendy Klagg Center for Autism at John Hopkins.

The first is that the definition of autism was broadened by the psychiatric community in 2013, so more people now qualify for an autism diagnosis.

Secondly, there has been a push for better screening of children, especially babies, for signs of autism. That push for increased awareness of the symptoms has been accompanied by a greater acceptance of the disorder, so people are not as afraid to seek help or to be identified as having autism, Ladd-Acosta said on the Johns Hopkins podcast “Public Health on Call.”

An HHS spokesperson said Friday that the agency is “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.”

Several studies have looked at the association between acetaminophen use in pregnancy and the development of autism in children, but experts say the science behind this theory is not settled.

A 2024 study published in JAMA looked at more than 2 million children born in Sweden between 1995 and 2019, about 185,000 of the whom were born to mothers who used acetaminophen during pregnancy. The study compared autism rates between these children with their siblings and with children who were not exposed, and it found that acetaminophen use during pregnancy was not associated with an increased risk of autism, attention deficit hyperactivity disorder or other neurodevelopmental disorders.

A meta-analysis published in August in the journal BMC Environmental Health looked at 46 studies on the use of acetaminophen during pregnancy and neurodevelopmental disorders in children. Six of the studies looked specifically at acetaminophen and autism. Overall, the analysis concluded that there was “strong evidence of an association” between taking acetaminophen during pregnancy and the development of autism in children, but the authors caution that their paper can show only associations, not that acetaminophen causes autism.

“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote.

The US Food and Drug Administration reviewed the risks of certain types of pain relievers during pregnancy in 2015 and said that all the studies it reviewed had methodological flaws. As a result, the agency said it would not change its recommendations for pain medications during pregnancy at that time.

The Society for Maternal-Fetal Medicine also reviewed the issue in 2017. It concluded that “the weight of evidence is inconclusive regarding a possible causal relationship between acetaminophen use and neurobehavioral disorders in the offspring.”

The Autism Science Foundation said in a statement Friday that “Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature given the current science. … The Autism Science Foundation strongly supports research into autism’s causes. More research needs to be done before alarming families or suggesting steps that may not actually reduce risk.”

HHS Secretary Robert F. Kennedy Jr. has previously promoted debunked theories linking vaccines to autism, and he pledged in April that his agency would have answers this month on the causes of autism. Thousands of researchers from top universities and institutions have applied for federal funding for autism research that Kennedy announced in April, and the US National Institutes of Health is expected this month to announce up to 25 awardees for the $50 million effort.

“We’re finding … certain interventions now that are clearly, almost certainly causing autism, and we’re going to be able to address those in September,” Kennedy said in a Cabinet meeting last month, to which President Donald Trump responded, “There has to be something artificial causing this, meaning, a drug or something.”

Dr. Peter Hotez, a pediatrician who co-directs the Center for Vaccine Development at Texas Children’s Hospital, said it would be irresponsible for Kennedy to cast any one or two things as a “smoking gun” cause of autism.

“That’s not how it works,” said Hotez, who has a daughter with autism and has written a book about the condition.

“We have autism genes, and it’s really important to look at some of the environmental toxins out there that are interacting with autism genes. And it may be possible to compile a list. … But I think it would be reckless to hone in just on those two, at least in terms of the publicly available data,” he said.

Shares of Kenvue fell about 10% midday after the Wall Street Journal report came out.

CNN’s Ramishah Maruf, Sarah Owermohle and Nadia Kounang contributed to this report.

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