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Trump administration links acetaminophen use in pregnancy to autism risk; experts urge caution

September 23, 2025

During a press briefing on Monday, September 22, officials from the Trump administration stated that using acetaminophen during pregnancy may raise the chances of a child developing autism. The briefing featured remarks from President Donald Trump, Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, and other senior health officials.¹

Late Monday, the FDA began updating safety labels for acetaminophen products to reflect that its use during pregnancy may be linked to a higher risk of neurological conditions like autism and ADHD in children. The agency also issued a nationwide alert to physicians, emphasizing that while a causal link hasn't been confirmed, precautionary use is advised.²

Medical experts and professional societies, including the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists, continue to support acetaminophen as the safest option for pain and fever relief during pregnancy when used appropriately. Kenvue, the manufacturer of Tylenol, strongly refuted the administration’s claims, citing decades of research showing no causal link between acetaminophen and autism. Critics warn that discouraging its use without clear evidence may lead pregnant patients to forgo necessary treatment or turn to riskier alternatives.³

In parallel, FDA initiated the approval process for leucovorin calcium (Wellcovorin; brand not currently marketed in the U.S.) tablets to treat cerebral folate deficiency, a condition linked to autism-like symptoms. The agency is working with GSK to update the drug’s labeling and ensure safe use, while emphasizing the need for further research in broader patient populations.

NIH also announced the launch of the Autism Data Science Initiative (ADSI), providing more than $50 million to fund 13 research projects aimed at advancing autism-related data science.⁴

Sources:

1. Christensen J, Dillinger K, Tirrell M. (2025, September 22). CNN. FDA will advise doctors about link between autism, acetaminophen use during pregnancy, Trump says. https://www.cnn.com/2025/09/22/health/trump-autism-announcement-cause-tylenol

2. (2025, September 22). FDA. FDA Takes Action to Make a Treatment Available for Autism Symptoms [FDA News Release]. https://www.fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms

3. Constantino, AK. (2025, September 22). CNBC. Trump admin draws unproven link between autism and Tylenol ingredient use during pregnancy. https://www.cnbc.com/2025/09/22/trump-autism-tylenol-acetaminophen-pregnancy.html

4. (2025, September 22). U.S. Department of Health and Human Services. President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism Epidemic [Press Release]. https://www.hhs.gov/press-room/hhs-trump-kennedy-autism-initiatives-leucovorin-tylenol-research-2025.html