PUBLIC HEALTH

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

Anthony Calabro, MA

Federal health officials have advised against the use of acetaminophen during pregnancy unless to treat fever, citing research on potential risks to child neurodevelopment. Federal officials also announced that they are planning a label change on the risk of acetaminophen during pregnancy.

The move follows an August 2025 review1 by Mount Sinai and Harvard researchers that analyzed more than 40 studies. In their review, researchers found associations between acetaminophen exposure in pregnancy and an increased risk of autism and other neurodevelopmental disorders in children. Officials are expected to caution pregnant women against routine use of the widely used medication early in their pregnancy.

Additionally, federal officials are recommending the use of leucovorin, a medication more commonly used to treat vitamin B9 deficiency, as a treatment for autism. The FDA issued an official notice to physicians noting that it was approving the tablet form of the medication to treat symptoms for children with autism who have cerebral folate deficiency. Double-blind, placebo-controlled trials studying leucovorin in select group of children with this form of autism have shown improvements in speech and language abilities.2,3

The NIH also announced a new autism science initiative with research teams, with the federal government investing $50 million in studies related to the causes of autism.

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. Environmental Health. 2025;24(1):56. doi:10.1186/s12940-025-01208-0.
  2. 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
  3. 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