According to reports citing people familiar with the matter, HHS may release a report this month addressing potential links between prenatal acetaminophen use, low folate levels, and autism; HHS says any claims about contents are speculation until publication.
For decades, acetaminophen (Tylenol) has been the go-to pain reliever for pregnant women. Now, it’s under new scrutiny.
The Wall Street Journal reports that the upcoming Department of Health and Human Services report will highlight prenatal Tylenol use and low maternal folate as potential autism factors. The report is also expected to suggest folinic acid (a form of folate) as a possible treatment for some autism symptoms, though HHS has not confirmed these details.
An HHS spokesperson responded: “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.”
This isn’t the first time RFK Jr. has raised concerns about acetaminophen. In July 2022, he shared on social media: “The authors of a new review of the drug acetaminophen, sold under the brand names Tylenol and Panadol, called for the immediate end of the use of the drug in infants and children.” In January 2023, he noted: “Hundreds of ‘Tylenol lawsuits’ already have been filed against retailers and manufacturers of acetaminophen — but that number could soon reach into the thousands.”
The scientific community remains divided on the Tylenol-autism connection.
Last month, Mount Sinai researchers reviewed 46 studies covering over 100,000 participants and found that better-quality research was more likely to show links between prenatal acetaminophen and autism or ADHD. This review found associations but did not prove causation.
The paper explores biological mechanisms that could explain the association. Acetaminophen is known to cross the placental barrier and may potentially trigger oxidative stress, disrupt hormones, and cause epigenetic changes that interfere with fetal brain development.
However, a major Swedish study published in JAMA in 2024 examined 2.4 million children and found no increased autism risk when comparing siblings who were exposed to acetaminophen during pregnancy with those who weren’t. This suggests family factors might explain earlier associations rather than the medication itself.
Despite the upcoming report, medical organizations haven’t changed their recommendations.
The American College of Obstetricians and Gynecologists (ACOG) continues to identify acetaminophen as one of the few safe pain options during pregnancy, noting there’s no clear evidence linking proper use to developmental issues.
Kenvue, Tylenol’s maker, stated they “continuously evaluated the science and continue to believe there is no causal link” between acetaminophen during pregnancy and autism.
The report is also expected to discuss how folate levels might relate to autism.
Research identifies folate receptor-alpha autoantibodies in a subset of children with ASD; these antibodies can impair folate transport into the brain (cerebral folate deficiency) in some cases.
Small randomized trials have reported improvements in verbal communication for some children—especially those positive for folate-receptor autoantibodies—but evidence is preliminary and not widely accepted as standard care.
NIH has announced up to $50 million in awards for a new Autism Data Science Initiative; this comes on top of NIH’s existing autism research portfolio, which runs in the hundreds of millions annually.
What Parents Should Know
Health experts recommend pregnant women:
- Use acetaminophen only when necessary
- Take the lowest effective dose for the shortest time
- Consult healthcare providers before using any medication
- Remember that untreated fever during pregnancy carries its own health risks
Autism diagnoses continue to rise, with approximately 1 in 31 children diagnosed by age 8 in 2022, up from 1 in 36 in 2020, according to CDC data.