APhA, Coalition of Autism Scientists Cite Insufficient Data to Support Acetaminophen, Autism Link

Following the US Food and Drug Administration (FDA) initiation of a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting use by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children, the American Pharmacists Association (APhA) released a statement defending its use during pregnancy and urging patients to talk with their pharmacists and other health care providers.1

On September 22, 2025, President Donald J. Trump and US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr announced the acetaminophen label change as well as a label update for leucovorin for cerebral folate deficiency (CFD), establishing it as the first FDA-recognized therapeutic for children with cerebral folate deficiency and autistic symptoms.2

“The American public relies upon our nation's pharmacists to make recommendations for the use of products to treat minor, self-limiting illnesses with nonprescription drugs, including acetaminophen,” APhA wrote in the statement.1 “As the health care providers responsible for ensuring the appropriate outcomes from medicines, including nonprescription drugs, pharmacists rigorously review the science to ensure their recommendations are best for the patients under their care. Americans should continue to trust the advice of their personal pharmacist and other health care providers.”

In a similar vein, the Coalition of Autism Scientists released a statement opposing the US HHS report suggesting an association between acetaminophen and autism, citing shortcomings of studies supporting this link and instead referencing recent research that, after controlling for unmeasured familiar risks, found acetaminophen did not cause autism.3

Similarly, in the September 23, 2025, statement, APhA said there has been no new evidence in 2 decades that the use of acetaminophen during pregnancy causes autism. Instead, they cite what they describe as “2 [of the] most reputable studies” suggesting no significant associations between the use of acetaminophen during pregnancy and children's risk of autism, ADHD, or intellectual disability.1

Data from the US Centers for Disease Control and Prevention suggests a steady rise in the prevalence of autism in children in the US, increasing from 1 in 150 children in 2000 to 1 in 31 children in 2022.4

“There is no need for concern. The United States is not experiencing an autism epidemic, nor is autism a new phenomenon,” Helen Tager-Flusberg, PhD, a professor at Boston University and founder of the Coalition of Autism Scientists, explained in an interview with The Educated Patient.5 “Autism rates continue to rise because researchers and clinicians increasingly understand how to identify characteristics of ASD. Each year, we are improving pediatric screening for autism, making more referrals to experts for diagnosis and offering better services for very young children. These changes across different parts of the US are reflected in the rising prevalence rates.”

Tager-Flusberg also cites the lack of an uptick in use of acetaminophen during pregnancy over the past 2 decades alongside rates of autism as “clearly not [being] related to the increase in prevalence rates,” a view reflected in a recent statement from the Coalition of Autism Scientists and shared by both the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) in recent statements.2,3

As described by the FDA, the acetaminophen label change is in response to prior clinical and laboratory studies suggesting a potential association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes, including the Nurses’ Health Study II and the Boston Birth Cohort. Of note, the Agency said it also recognizes that there are contrary studies showing no association and that there can be risks for untreated fever in pregnancy, both for the mother and fetus.2

“While it is appropriate to continuously monitor drug safety signals and review emerging research, claims that are not rooted in science are confusing to patients and health care providers who are caring for and counseling patients during pregnancy,” APhA wrote.1 “Based on the current literature, acetaminophen remains a safe option for people who are pregnant when used appropriately. APhA will continue to defend science and uphold rigorous evidence-based evaluations for our patients, free from any influence from special interests.”

References

1. American Pharmacists Association. APhA alarmed by claims of harm from acetaminophen without substantive science. September 23, 2025. Accessed September 30, 2025. https://www.prnewswire.com/news-releases/apha-alarmed-by-claims-of-harm-from-acetaminophen-without-substantive-science-302565063.html

2. Brooks A. ACOG, AAP Respond to White House Autism Announcements on Acetaminophen, Leucovorin. HCPLive. September 24, 2025. Accessed September 30, 2025. https://www.hcplive.com/view/acog-aap-respond-white-house-autism-announcements-acetaminophen-leucovorin

3. Coalition of Autism Scientists. Autism Scientists Strongly Oppose HHS Report Suggesting Links Between Tylenol and Autism; Use of Leucovorin. September 22, 2025. Accessed September 30, 2025. https://www.coalitionofautismscientists.org/

4. CDC. Data and Statistics on Autism Spectrum Disorder. May 27, 2025. Accessed September 30, 2025. https://www.cdc.gov/autism/data-research/index.html

5. Tager-Flusberg H. Sorting Facts From Misinformation About Autism. September 25, 2025. Accessed September 30, 2025. https://www.theeducatedpatient.com/view/sorting-facts-from-misinformation-about-autism