Trump Administration Claims Link Between Autism and Acetaminophen Use in Pregnancy
As part of this announcement, the administration launches initiatives across the National Institutes of Health, the FDA, and the Center for Medicare & Medicaid Services.
The Trump administration called out acetaminophen (Tylenol) as a potential cause to autism spectrum disorder during a press conference September 22, 2025. As part of this announcement, the administration launched initiatives across the National Institutes of Health (NIH), the FDA, and the Center for Medicare & Medicaid Services.
As part of this announcement, the administration launches initiatives across the National Institutes of Health, the FDA, and the Center for Medicare & Medicaid Services. | Image Credit: Matthew Benoit - stock.adobe.com
“Since 2000, autism rates have surged by more than 400%,” President Donald Trump said in the press conference. “Taking Tylenol is not good...for this reason, they are strongly recommending limiting Tylenol use in pregnancy.”
Acetaminophen is generally accepted as a safe medication when taken appropriately, and there is no safe alternative to decrease fever during pregnancy, which Trump acknowledged in the press conference. Jaspreet Kaur, BAMS, MPH, PhD, a research fellow of translational medicine in the School of Medicine at the University of Nottingham, United Kingdom, told Drug Topics® earlier this year that acetaminophen is considered the safest analgesic for mild to moderate pain and has been widely available in OTC drugs, with nearly 500 OTC products containing the drug.1,2
Trump Administration Initiatives
In the press conference, Trump said that “if you cannot tough it out [the pain and fever], then you will take Tylenol.” However, he also said, “ideally, you won’t take it at all.” He also claimed that a pregnant person should not take Tylenol during the entire pregnancy, and it should not be given to children.
The NIH launched the Autism Data Science Initiative, which received an additional $50 million to accelerate ASD research. Peer reviewers chose the 13 best projects to determine the cause and potential therapies for ASD, which included replication and validation studies.3 According to Health and Human Services Secretary Robert F. Kennedy Jr, NIH is currently testing multiple areas with nothing off limits. He acknowledged that there are studies that show no association between ASD and acetaminophen and that there is no alternative for fever relief. The FDA will issue a physician notice and update the safety label change for acetaminophen, both Tylenol and other products. HHS will also launch a nationwide service campaign to educate and inform the general public.4
Furthermore, Kennedy stated that the FDA will publish a Federal Register notice for a label update to leucovorin for cerebral folate deficiency, which he stated could lead to ASD.4
Current Evidence of Acetaminophen Use in Pregnancy
For pregnancy specifically, acetaminophen is considered safe to take and is preferred to nonsteroidal anti-inflammatory drugs, which pose pregnancy risks such as low amniotic fluid or fetal kidney problems, according to The University of Texas Southwestern Medical Center.5 However, many have questioned the safety of acetaminophen in pregnancy. Evidence has shown mixed results on the causation of acetaminophen in pregnancy and ASD.
An article published in JAMA Psychiatry found that cord biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood ADHD and ASD, supporting previous findings from the investigators. Of the 996 samples included, approximately 25.8% had ADHD, 6.6% had ASD, 4.2% had both ADHD and ASD, 30.5% had other developmental disorders, and 32.8% were neurotypical. Further, in a study using the Navigation Guide, investigators found 46 studies that were included in the analysis. Of these, 27 showed significant links to neurodevelopmental disorder, 9 had no link, and 4 showed protective effects.5-7
However, in the largest study to date, investigators found that acetaminophen use during pregnancy did not increase the risk of ASD. The sibling control analysis included 2,480,797 children born from 1995 to 2019 in Sweden, with 7.49% being exposed to acetaminophen during pregnancy. In the crude absolute risk analysis at 10 years of age, 1.33% of those not exposed and 1.53% of those exposed to acetaminophen developed ASD, 2.46% and 2.87%, respectively, developed ADHD, and 0.70% and 0.82% developed an intellectual disability. For models without sibling controls, acetaminophen use did show an increased risk of both ASD and intellectual disability, but in the matched sibling pairs, there was no evidence that acetaminophen was associated with either.8
The Pharmacist's Role in Education and Counseling
Pharmacists are not generally mentioned in clinical practice for ASD; however, in an article published in the Canadian Pharmacists Journal, investigators noted that patients with ASD are typically supported by an interdisciplinary team of both health professionals and educators. The authors noted that providing guidelines to community pharmacists can help bolster the impact on patients with ASD since pharmacists are generally positioned to improve disease management for patients through pharmacological expertise and communication skills.9
The role of the pharmacist is further highlighted in a consolidated tort, including 66 actions filed in Manhattan’s federal court in 2022. The tort claimed that the defendants named violated state law by not warning consumers about the risk that children may develop ASD and/or ADHD as a result of maternal acetaminophen use. The US District Judge in New York, Denise Cote, granted the defendants’ motion to exclude the general causation experts’ opinions about ASD, ADHD, and biological plausibility.10
The document reads, “The state of scientific evidence on prenatal use of acetaminophen presents a challenge for any expert witness offering the opinion that such use causes ADHD and ASD. The epidemiological evidence is highly heterogenous, and major medical organizations and regulators have cautioned against drawing causal inferences from the existing body of scientific literature.”10
Pharmacists are positioned to help communicate current scientific evidence to the general public in clear and patient-friendly ways. In a commentary published in the Journal of the American College of Clinical Pharmacy, the authors wrote that pharmacist interventions are often at the intersection of medication management and health information. They list actionable steps for pharmacists, including gathering information and sources, using communication tools effectively, and remaining intentional about actions taken after an encounter and follow-up.11
READ MORE: Pediatrics Resource Center
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REFERENCES
1. Gallagher A. Acetaminophen misuse in older adults raises concerns about liver damage. Drug Topics. August 22, 2025. Accessed September 22, 2025. https://www.drugtopics.com/view/acetaminophen-misuse-in-older-adults-raises-concerns-about-liver-damage
2. Acetaminophen Awareness Coalition. Common medicines with acetaminophen. Accessed September 22, 2025. https://www.knowyourdose.org/acetaminophen-dosing-calculator/
3. Bhattacharya J, Makary M, Oz M. Opinion | The Trump administration’s new steps to tackle autism. Politico. September 22, 2025. Accessed September 23, 2025. https://www.politico.com/news/magazine/2025/09/22/autism-trump-nih-fda-cms-op-ed-00575420
4. President Trump, Secretary Kennedy announce bold actions to tackle autism epidemic. News release. Health and Human Services. September 22, 2025. Accessed September 23, 2025. https://www.hhs.gov/press-room/hhs-trump-kennedy-autism-initiatives-leucovorin-tylenol-research-2025.html
5. UT Southwestern Medical Center. Acetaminophen is still safe in pregnancy, despite controversy. November 7, 2022. Accessed September 22, 2025. https://utswmed.org/medblog/acetaminophen-pregnancy-safety/
6. Ji Y, Azuine RE, Zhang Y, et al. Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in childhood. JAMA Psychiatry. 2020;77(2):180-189. doi:10.1001/jamapsychiatry.2019.3259
7. Prada D, Ritz B, Bauer AZ, Baccarelli AA. 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
8. Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen use during pregnancy and children’s risk of autism, ADHD, and intellectual disability. JAMA. 2024;331(14):1205-1214. doi:10.1001/jama.2024.3172
9. Kadi R, Gayed F, Kauzman P, et al. Autism spectrum disorder: Practice guidelines for pharmacists. Can Pharm J (Ott). 2024;157(2):58-65. doi:10.1177/17151635241228495
10. Acetaminophen – ASD-ADHD Products Liability Litigation. NY 1:22-md-03043-DLC (2023).
11. Harris IM, Hilaire ML, Jeon M, et al. Pharmacists' role in combating medical misinformation. J Am Coll Clin Pharm. 2024;1-5. doi:10.1002/jac5.2005
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