Federal Officials Plan Label Change on the Risk of Acetaminophen Use During Pregnancy Citing Link to Autism, Tout Leucovorin as Treatment Option

At a White House press conference, federal officials announced plans to update acetaminophen labeling to include a caution about potential risks when used during pregnancy. The officials cited a recent review by Mount Sinai and Harvard researchers that examined more than 40 observational studies reporting associations between prenatal acetaminophen exposure and increased risk of autism and other neurodevelopmental outcomes in children.¹

Authors of one large cohort analysis² previously emphasized that they found no increased risk once family and genetic factors were accounted for. Additionally, on September 22, 2025, the American College of Obstetricians and Gynecologists (ACOG) released a new statement affirming that acetaminophen remains a safe and important option during pregnancy, warning that claims of causation are “not backed by the full body of scientific evidence.”³ The World Health Organization similarly noted that evidence linking acetaminophen use in pregnancy to autism is inconsistent.⁴

Additionally, at the White House press conference, federal officials pointed to leucovorin, a folate-related medication, as a potential therapy for a subset of children with autism who have cerebral folate deficiency. Double-blind, placebo-controlled trials in this subgroup have demonstrated improvements in speech and language abilities, though the authors, in those same studies, caution that these findings cannot be generalized to all children with autism.^5,6

The National Institutes of Health also announced a new autism science initiative with $50 million in federal funding to support research into the biological causes and potential treatments for autism spectrum disorder.

Obstetric and pediatric experts continue to advise that acetaminophen may be used during pregnancy when medically necessary, particularly for treating fever, which itself can pose risks to fetal development if left untreated.^3,7

This article has been updated from its original version to include comments from the American College of Obstetricians and Gynecologists on September 23, 2025.

References

1. Prada D, Ritz B, Bauer AZ, Baccarelli AA, et al. Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology. Environ Health. 2025;24(1):56. doi:10.1186/s12940-025-01208-0

2. Gustavson K, Ask H, Ystrom E, et al. Acetaminophen use during pregnancy and offspring attention-deficit/hyperactivity disorder—a sibling-control cohort study. JAMA Psychiatry. 2021;78(1):1-10. doi:10.1001/jamapsychiatry.2020.3426

3. American College of Obstetricians and Gynecologists. ACOG affirms safety and benefits of acetaminophen during pregnancy. News release. September 22, 2025. Accessed September 23, 2025. https://www.acog.org/news/news-releases/2025/09/acog-affirms-safety-benefits-acetaminophen-pregnancy

4. World Health Organization. WHO statement on paracetamol use during pregnancy. September 23, 2025. Accessed September 23, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/who-says-evidence-inconsistent-link-between-autism-paracetemol-use-pregnancy-2025-09-23

5. Frye RE, Rossignol DA, Scahill L, McDougle CJ, Huberman H, Quadros EV. Treatment of folate metabolism abnormalities in autism spectrum disorder. Semin Pediatr Neurol. 2020;35:100835. doi:10.1016/j.spen.2020.100835

6. Panda PK, Sharawat IK, Saha S, Gupta D, Palayullakandi A, Meena K. Efficacy of oral folinic acid supplementation in children with autism spectrum disorder: a randomized double-blind, placebo-controlled trial. Eur J Pediatr. 2024;183(11):4827-4835. doi:10.1007/s00431-024-05762-6

7. American Academy of Pediatrics. AAP Statement on White House Autism Announcement. News release. September 22, 2025. Accessed September 23, 2025. https://www.aap.org/en/news-room/news-releases/aap/2025/aap-statement-on-white-house-autism-announcement/