Trump Administration Says Prenatal Acetaminophen Use Linked to Autism

The Trump administration announced that the use of acetaminophen during pregnancy may increase a child’s risk for autism.

At a press conference, President Donald Trump said a review of existing data suggest there is a link between acetaminophen use and an increase in autism and other neurodevelopmental disorders (NND) in children. The President was joined by US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, National Institutes of Health (NIH) Director Dr Jay Bhattacharya, Food and Drug Administration (FDA) Commissioner Dr Marty Makary, and Centers for Medicare and Medicaid Services (CMS) Administrator Dr Mehmet Oz.

The announcement comes after a recently published review showed an association between prenatal acetaminophen exposure and an increased risk of NNDs. The study, led by researchers at the Icahn School of Medicine at Mount Sinai, employed Navigation Guide methodology to evaluate 46 studies with over 100,000 participants. 

Although a cause-and-effect relationship could not be established, the researchers cautioned that based on their findings, acetaminophen use during pregnancy should be limited to the lowest dose for the shortest duration. They also noted that not treating a fever or pain during pregnancy could pose significant risks to the mother and child. 

While studies such as the Nurses’ Health Study II and the Boston Birth Cohort have pointed to a correlation between acetaminophen use during pregnancy and subsequent autism diagnosis, others have shown no association. 

Acetaminophen is commonly known under the brand name Tylenol. The over-the-counter (OTC) pain and fever reliever is regarded by both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) as a safe medication for use during pregnancy. In a recent statement, the SMFM noted that “all of the studies to date, including the most recent research, have significant methodological and design limitations and do not clearly establish the link between acetaminophen and childhood neurobehavioral issues.”

During the press conference, Makary said that the FDA would begin the process of updating acetaminophen drug labels with the new safety information. The Agency also plans to send a notice to physicians alerting them to the potential risks. 

Additionally, Makary stated that the FDA intends to file a federal register notice to allow for the use of leucovorin, a folate analog, in the treatment of autism. Leucovorin is currently approved by the FDA as a rescue medication for methotrexate toxicity. It is also indicated for use in the treatment of megaloblastic anemia and advanced colorectal cancer. 

Findings from a double-blind, placebo-controlled, randomized study published last year showed that folinic acid supplementation improved autism spectrum disorder (ASD) symptoms in children, especially in those with high levels of folate receptor autoantibodies. Folate receptor autoantibodies are known to be more prevalent in children with ASD and play a significant role in the pathology.

In a subsequent press release, the new Director of the FDA’s Center for Drug Evaluation and Research, Dr George Tidmarsh, said that the Agency would be working with GSK to broaden the existing label for Wellcovorin. 

Regarding future autism research, Bhattacharya said the NIH has launched the Autism Data Science Initiative, with 50 million dollars already earmarked for the project. The trials will explore all the possible factors that may contribute to ASD, including environmental and medical causes. 

In response to the claims made by the Administration, Kenvue, the makers of Tylenol, issued the following statement:

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents.” 

The Company went on to say that based on available scientific evidence, acetaminophen continues to be the safest option for pregnant women who are in need of pain relief or fever reduction. They also noted that the safety of the drug has been confirmed in numerous pediatric trials.   

“The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism.”

Last Updated: September 25, 2025

This article originally appeared on MPR