Association between Autism and acetaminophen use during pregnancy
President Donald J. Trump, joined by Health and Human Services Secretary Robert F. Kennedy, Jr., addressed the nation from the Roosevelt Room today, unveiling a sweeping set of actions to confront what they described as an “autism epidemic.” Autism now affects an estimated 1 in 31 American children, a nearly 400% rise since 2000. Citing newly released prevalence data, the Trump administration made the case for immediate, coordinated federal intervention to stem what the President called “one of the most alarming public health developments in American history.” Sec. Kennedy has made finding the possible causes of autism a significant priority, including the a possible connection between acetaminophen taken during pregnancy and austism.
In April, HHS reported a new Autism and Developmental Disabilities Monitoring (ADDM) report was conducted in 2022 across 16 sites in the U.S. and surveyed children aged 8 years born in 2014. This latest autism prevalence is 4.8 times higher than in the first ADDM survey 22 years ago, when prevalence was 1 in 150 children.
“For too long, families have been left without answers or options as autism rates have soared,” Secretary Kennedy said.“Today, we are taking bold action—opening the door to the first FDA-recognized treatment pathway, informing doctors and families about potential risks, and investing in groundbreaking research. We will follow the science, restore trust, and deliver hope to millions of American families.”
Unprecedented Federal Response
Trump and Kennedy outlined a trio of new initiatives, calling on the National Institutes of Health (NIH), the Food & Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS) to accelerate research. They urged the agencies to clarify guidance for parents and doctors, and open up new avenues for potential autism treatments. These efforts will work across agencies and aim to rapidly translate emerging research into practical support for families—breaking, in their words, “the bureaucratic walls” that have slowed past public health responses.
Policy Changes and Research Funding
Among the most notable announcements:
Expanded Medicare and Medicaid coverage for select therapies and new pilot programs to reach underserved communities.
Acetaminophen, Autism, and Controversy
Additionally, the announcement comes amid fierce debate about the role of common medications in ASD risk. Trump and Kennedy both referenced concerns, echoing recent White House communications, about a potential association between prenatal acetaminophen exposure and later autism diagnosis. While administration figures described the science as “emerging but actionable,” leading medical experts and organizations from the U.S. and abroad have pushed back, stating that current evidence remains inconclusive and advising against policy decisions that restrict access to necessary pain and fever relief pending further study.
The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related letter alerting physicians nationwide.
Community and Scientific Response
Autism advocacy groups, scientific organizations, and many clinicians issued statements welcoming federal focus but urged caution. Some warned that overstating uncertain risks, or advancing unproven therapies, could overwhelm already anxious parents or distract from the strongest known interventions—like early, evidence-based behavioral support. The American College of Obstetricians and Gynecologists, among others, stated that acetaminophen remains the safest recommended option for pregnant women who need pain or fever reduction, and that a focus on awareness and individualized care is critical.
A Harvard-led study published in BMC Environmental Health analyzed 46 prior studies and found evidence of an association between prenatal acetaminophen (Tylenol) exposure and increased risk of neurodevelopmental disorders, including autism and ADHD, in children. The association was strongest with heavy or prolonged use of acetaminophen during pregnancy. Researchers advised cautious, medically guided acetaminophen use, using the lowest effective dose for the shortest duration, rather than imposing broad limitations, and emphasized the need for further research to confirm causality.
Likewise, researchers at the Icahn School of Medicine at Mount Sinai have found that prenatal exposure to acetaminophen may increase the risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD), in children. The peer-reviewed study, published in August 2025 in BMC Environmental Health, is the first to apply the rigorous Navigation Guide methodology to systematically evaluate the rigor and quality of the scientific literature.
Looking Forward
With the announcement, the Trump administration has signaled a new, aggressive federal posture on autism. Officials, led by Secretary Kennedy, committed to public “accountability and transparency” in reporting results of these efforts each year. Whether these bold actions will mark a turning point in understanding and supporting children with ASD and their families remains to be seen, but for many, the scale and speed of the response marks an unprecedented moment in national autism policy.
“Millions of American families who care for autistic kids need scientists to apply gold standard science, expertise, and open minds to figure out how to help these kids,” NIH Director Dr. Jay Bhattacharya said. “With the Autism Data Science Initiative, NIH is harnessing cutting-edge science to uncover the root causes of autism. We are building knowledge that can improve lives and restore hope for families.”
