According to The Wall Street Journal and coverage by Reuters, the upcoming Department of Health and Human Services (HHS)-led report — primarily drafted by the National Institutes of Health (NIH) — is set to suggest a potential link between acetaminophen (Tylenol) use during pregnancy and an increased risk of autism in children. It will also highlight low maternal folate levels as a possible contributing factor and propose using folinic acid (a folate derivative) as a treatment to help mitigate autism symptoms in some individuals.
Tylenol is manufactured by McNeil Consumer Healthcare, a division of Kenvue, which was spun off from Johnson & Johnson into an independent consumer health company.
Acetaminophen is one of the most widely used analgesics (pain relievers) and antipyretics (fever reducers) worldwide.
It is the active ingredient in hundreds of OTC products, such as:
- Single-ingredient pain relievers/fever reducers
- Store-brand acetaminophen tablets (CVS, Walgreens, Walmart’s Equate, etc.)
- Combination medications
- Cold & flu products: NyQuil, DayQuil, Theraflu, Alka-Seltzer Plus Cold
- Migraine/headache products: Excedrin (acetaminophen + aspirin + caffeine)
- Menstrual relief: Midol Complete (acetaminophen + caffeine + pyrilamine maleate)
- Allergy & sinus medications: Tylenol Sinus, Sudafed PE Head Congestion + Pain
The Wall Street Journal continues:
“Nothing is more important to us than the health and safety of the people who use our products,” a Kenvue spokeswoman said. “We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism.”
For months Kennedy has promised to reveal the cause of autism. “By September we will know what has caused the autism epidemic,” he said in an April cabinet meeting with President Trump.
Critics panned the promise as an impossible timeline if the government were to conduct a valid scientific inquiry. Kennedy’s advisers were more cautious, promising instead to launch a National Institutes of Health research effort by September.
The report being prepared by health department staff takes a measured approach, people familiar with the matter said, listing possible causes for the disorder and discussing what is known and unknown about autism. The NIH is taking the lead on drafting the report, which is set to be released later this month, the people said. It is largely expected to be based on existing research.
A systematic review by the Icahn School of Medicine at Mount Sinai (published in August 2025) found associations between prenatal acetaminophen exposure and the risk of autism and ADHD, based on rigorous review methods. However, the researchers stressed the need for cautious use under medical guidance.
Earlier studies, including archived data from NIH-funded research, similarly linked acetaminophen exposure in utero with higher odds of neurodevelopmental disorders — but these are observational and don’t prove a causal relationship.
One of the largest sibling-based studies — conducted in Sweden and published in JAMA — found no causal link between prenatal acetaminophen exposure and autism, ADHD, or intellectual disability. The sibling-comparison method helps control for both genetic and environmental confounders.
Kennedy’s report is still in development and may undergo White House review before its release. Kenvue’s stock over 15% dropped after the news broke.
HHS did not immediately respond to a request for comment.
This is a breaking news story. Please check back for updates.
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With my pregnancies from 1987 to 1997 I would absolutely not take prescription drugs or OTC drugs. There was zero shots pushed on pregnant women because of the unknown dangers to the pre-born baby. I cannot fathom any doctor who has a brain recommending these today. I’m still very anti-drug and doing just fine at 68 years old.