HHS Report Expected to Link Prenatal Tylenol Use and Autism Risk

The Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. are expected to release a report linking use of Tylenol (acetaminophen; Johnson & Johnson) during pregnancy to autism spectrum disorder (ASD), according to the Wall Street Journal. The forthcoming document will reportedly review existing research, including a large Swedish cohort study, as well as evidence regarding maternal folate levels during pregnancy.¹

Box of extra strength Tylenol | Image Credit: © Birch Photography - stock.adobe.com

The report follows Kennedy’s earlier announcement of a large-scale federal initiative to investigate the causes of ASD, a condition that affects approximately 1 in 31 children in the United States, according to the CDC. If released as described, this report would mark one of the first official federal attempts to attribute ASD risk to a widely used over-the-counter medication.^1-3

The anticipated report further raises concerns about how preliminary or inconclusive scientific data are disseminated to the public. Past public health debates—such as those surrounding vaccines and autism—illustrate how selective reporting or oversimplified messages can fuel confusion, distrust, and stigma.

The Swedish Study

One of the most frequently cited investigations into acetaminophen and ASD risk is a large population-based cohort study conducted in Sweden and published in JAMA in 2024. Researchers followed more than 2.4 million children born between 1995 and 2019, linking national registry data on prescription fills, hospital records, and diagnoses of developmental conditions.⁴

The researchers found that duration and frequency of exposure mattered. Children whose mothers reported frequent or prolonged acetaminophen use during pregnancy had a modestly increased risk of both ASD and attention-deficit/hyperactivity disorder (ADHD). The hazard ratios suggested an approximate 20% to 30% increased risk compared with children with no reported exposure. However, absolute risk remained small.⁴

Maternal conditions requiring acetaminophen—such as infections, fever, or chronic pain—were also associated with neurodevelopmental outcomes, leaving researchers unable to completely separate whether the medication itself or the underlying maternal condition contributed to the observed risks.⁴

However, most notably from the study, when researchers performed a sibling-controlled analysis, there was no significant association found between prenatal acetaminophen and risk of ASD (Hazard Ratio [HR], 0.98; 95% CI, 0.93–1.04), ADHD (HR, 0.98; 95% CI, 0.94–1.02), or intellectual disability ((HR, 1.01; 95% CI, 0.92–1.10). noted that the study was observational and could not prove causality. The sibling analysis substantially strengthens the notion that acetaminophen exposure in pregnancy is unlikely to cause autism, ADHD, or intellectual disability, once you control for familial and environmental factors.⁴

Folate and ASD

Folate is critical for early brain and spinal cord development, and folic acid supplementation before and during pregnancy has long been recommended to prevent neural tube defects. Emerging research examines whether inadequate folate exposure may contribute to risk of autism and related neurodevelopmental disorders.⁵

Several large cohort studies in Norway, the United States, and Israel suggest that mothers who took folic acid supplements around conception had a lower risk of having a child with autism, in some cases by as much as 30% to 70%. However, findings have not been consistent. The Danish National Birth Cohort, for example, did not observe a significant association, and differences in timing, dosage, and measurement of folate exposure may partly explain the discrepancies. Overall, the weight of evidence suggests that inadequate folate during early pregnancy may increase autism risk, while appropriate supplementation is likely protective.⁵

Folate has also been studied beyond prevention. Early randomized controlled trials of leucovorin (folinic acid)—a form of folate that can cross into the brain when transport is impaired—have suggested potential benefits for certain autism symptoms. Results across these small studies have been mixed and often tied to specific genetic variants, so the evidence remains preliminary. More research is needed before folinic acid can be considered an established treatment option.⁵

How Pharmacists Can Support Patients

Pharmacists are often the most accessible health care professionals for patients with questions about medications in pregnancy. With heightened attention on acetaminophen and autism, pharmacists may find themselves fielding concerns from expectant mothers or families weighing risks and benefits.

Key strategies pharmacists can use to support patients include:

• Contextualizing the evidence: Explaining that current studies show associations, not causation, and that the scientific community has not reached consensus.
• Encouraging balanced risk-benefit analysis: Helping patients weigh the potential risks of acetaminophen against the risks of untreated pain, fever, or other conditions during pregnancy.
• Reinforcing prenatal best practices: Advising patients on the importance of folate supplementation, safe medication use, and regular prenatal care.
• Referring to obstetricians: Encouraging expectant parents to consult with obstetricians or maternal-fetal medicine specialists for individualized guidance.

As the forthcoming HHS report brings renewed public attention to these issues, pharmacists and other health care professionals will play a key role in guiding patients through the uncertainty. By providing context, reinforcing established prenatal care practices, and encouraging consultation with physicians, pharmacists can help ensure patients receive balanced, evidence-based support during pregnancy.

REFRENCES

1. Whyte L, Subbaraman N. RFK Jr., HHS to link autism to Tylenol use in pregnancy and folate deficiencies. Wall Street Journal. September 5, 2025. Accessed September 9, 2025. https://www.wsj.com/health/healthcare/rfk-jr-hhs-to-link-autism-to-tylenol-use-in-pregnancy-and-folate-deficiencies-e3acbb4c

2. Gerlach A. CDC launches study on vaccine-autism link amid ongoing measles outbreak. Pharmacy Times. March 21, 2025. Accessed September 9, 2025. https://www.pharmacytimes.com/view/cdc-launches-study-on-vaccine-autism-link-amid-ongoing-measles-outbreak

3. Data and Statistics on Autism Spectrum Disorder. CDC. May 27, 2025. Accessed September 9, 2025. https://www.cdc.gov/autism/data-research/index.html

4. Ahlqvist V, Sjöqvist H, Dalman C, et al. Acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability. JAMA. April 9, 2024. doi:10.1001/jama.2024.3172

5. Statement from Autism Science Foundation Regarding Wall Street Journal Report“RFK Jr., HHS to link autism to Tylenol use in pregnancy and folate deficiencies.” Autism Science Foundation. September 5, 2025. Accessed September 9, 2025. https://autismsciencefoundation.org/press_releases/statement-from-autism-science-foundation-regarding-wall-street-journal-report-rfk-jr-hhs-to-link-autism-to-tylenol-use-in-pregnancy-and-folate-deficiencies/