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ACOG, AAP Respond to White House Autism Announcements on Acetaminophen, Leucovorin
Both ACOG and AAP have released statements disagreeing with the FDA label change for acetaminophen to reflect autism risk in children if used during pregnancy.
The American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) have both released statements regarding the US Food and Drug Administration (FDA) initiation of a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.1,2
On September 22, 2025, President Donald J. Trump and US Health and Human Services Secretary (HHS) Robert F. Kennedy Jr announced this 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.3,4
“Today’s White House event on autism was filled with dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals,” the AAP wrote in a statement.2 “Studies have repeatedly found no credible link between life-saving childhood vaccines and autism. This research, in many countries, involving thousands of individuals, has spanned multiple decades. Any effort to misrepresent sound, strong science poses a threat to the health of children.”
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.3,4
“Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” Steven Fleischman, MD, MBA, president of ACOG, said in a statement.1 “Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children. It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.”
In the statement, Fleischman cites a lack of “reputable” studies successfully concluding that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children. He additionally points to methodological limitations of research suggesting such a link, including lack of a control for confounding factors or use of unreliable self-reported data.1
“Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it,” Fleischman said.1 “The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”
The FDA has also published a Federal Register notice outlining a label update for leucovorin for cerebral folate deficiency authorizing treatment for children with ASD, with continued use if children show language, social, or adaptive gains.3,4
The Agency is working with GSK, the innovator of leucovorin calcium (Wellcovorin), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort and is supporting this initiative by adding data from case reports identified by the FDA of genetically confirmed CFD into the US prescribing information.3,4
“There is no single, root cause of autism, and there is no single medication that will give every autistic child or adult what they need,” the AAP said in a statement.2 “Individualized plans, often involving a combination of developmental, behavioral, educational and social-relational strategies, can help improve outcomes that are meaningful to individuals and families. We also need and welcome additional investments in federally funded research to better support families of autistic children.”
References
ACOG. ACOG Affirms Safety and Benefits of Acetaminophen during Pregnancy. September 22, 2025. Accessed September 24, 2025. https://www.acog.org/news/news-releases/2025/09/acog-affirms-safety-benefits-acetaminophen-pregnancy
AAP. AAP Statement on White House Autism Announcement. September 22, 2025. Accessed September 24, 2025. https://www.aap.org/en/news-room/news-releases/aap/2025/aap-statement-on-white-house-autism-announcement/
Brooks A. FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate Deficiency. HCPLive. September 22, 2025. Accessed September 24, 2025. https://www.hcplive.com/view/fda-initiates-acetaminophen-label-change-leucovorin-approval-for-cerebral-folate-deficiency
HHS. President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism Epidemic. September 22, 2025. Accessed September 24, 2025. https://www.hhs.gov/press-room/hhs-trump-kennedy-autism-initiatives-leucovorin-tylenol-research-2025.html
