Physicians blast HHS claims about autism and acetaminophen during pregnancy

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Childhood autism is a new target for treatment by the U.S. Department of Health and Human Services (HHS).

But physician groups say claims about acetaminophen causing autism will confuse parents and families rightly concerned about the causes and effects of autism spectrum disorder (ASD).

On Sept. 22, HHS Secretary Robert F. Kennedy, Jr., and his top aides announced new “bold actions to tackle (the) autism epidemic.” Kennedy publicly has cited figures pointing to a 400% surge in diagnoses since 2000, with autism now affecting one in 31 American children.

“For too long, families have been left without answers or options as autism rates have soared,” Kennedy said in HHS’ official announcment. “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.”

Aiming at acetaminophen

Kennedy said HHS, working through the U.S. Food and Drug Administration, will act on acetaminophen with a new physician notice and safety label change for the drug, found in Tylenol and similar products.

“The FDA is responding to prior clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes,” HHS’ official announcement said. “FDA 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.”

Physicians and other clinicians must use their best judgment to treat fevers and pain during pregnancy, the HHS announcement said. Acetaminophen often is the only drug for those conditions during pregnancy, while other medicines, such as nonsteroidal anti-inflammatory drugs, have well-documented adverse effects.

‘No credible body of evidence’

Physician groups said they are united with the families and caregivers of children diagnosed with autism, in wanting more research and answers about the condition. But they panned the HHS pronouncement for its potential to confuse pregnant women, their families, parents and others concerned about child health.

The American Academy of Family Physicians (AAFP) was blunt about acetaminophen and vaccines, another favorite target of Kennedy.

“Vaccines do not cause autism. Decades of rigorous research have failed to provide credible scientific evidence linking vaccines to autism. Vaccines are among the most effective tools we have to keep people, especially infants and children, healthy and out of hospitals. Continued claims about a vaccine-autism link risk public health by causing people to delay or defer vaccination out of fear.

“There is also no credible body of evidence linking acetaminophen (commonly known as Tylenol) use in pregnancy to autism,” AAFP’s statement said. “The claim is unfounded and has been refuted by rigorous studies and systematic reviews.”

Where’s the reliable data?

American College of Obstetricians and Gynecologists (ACOG) President Steven J. Fleischman, MD, MBA, FACOG, said associating acetaminophen and autism was irresponsible, harmful and confusing.

The claims are “not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children,” Fleischman said. “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.”

Fleischman said there have been no reputable studies linking acetaminophen to neurodevelopmental disorders in children. Two of the highest-quality studies found no significant associations between use of acetaminophen during pregnancy and autism, attention deficit hyperactivity disorder, or intellectual disability.

“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,” Fleischman said in the statement. “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. 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.”

A scientific study

ACOG cited “the two highest-quality studies” on acetaminophen as a cause of autism. The two included “Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability,” published last year in JAMA.

Researchers followed a population of more than 2.48 million children born in Sweden from 1995 to 2019, with follow-up through the end of 2021. Among them, 185,909 (7.49%) were exposed to acetaminophen during pregnancy. The conclusion: “Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analysis.”

Other models showed associations between acetaminophen and neurodevelopmental disorders, but multiple biases and confounding with other factors may be the reasons for those findings, the study said.

‘Dangerous claims’

The American Academy of Pediatrics said the HHS announcement at the White House “was filled with dangerous claims and misleading information,” misrepresenting decades of strong science about vaccines and autism.

Children’s immune systems perform better after vaccinations against contagious diseases such as measles, whooping cough and hepatitis B, the AAP statement said.

“Regarding autism, we know it is complex, highly variable and increasingly linked to genetics,” the AAP statement said. “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. 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.”

Acetaminophen is appropriate

The Society for Maternal-Fetal Medicine (SMFM) reaffirmed its recommendation to physicians and patients that acetaminophen is appropriate for treating pain and fever during pregnancy.

“To be clear, SMFM stands behind our recommendation that acetaminophen use during pregnancy has not been shown to cause or increase the risk of autism or other neurobehavioral problems in children,” the society’s statement said. SMFM agreed continued research is needed to understand potential causes of neurodevelopmental disabilities in children.

Other actions on autism

The acetaminophen action was not the only initiative announced by the federal leaders.

FDA is publishing a Federal Register notice outlining a label update for leucovorin for cerebral folate deficiency, which has been associated with autism. The U.S. Centers for Medicare & Medicaid Services will work with state Medicaid programs to cover the drug for ASD. The National Institutes of Health will launch confirmatory trials and safety studies of leucovorin.

“While promising, it is important to note that leucovorin is not a cure for ASD and may only lead to improvements in speech-related deficits for a subset of children with ASD,” HHS’ announcement said. “Furthermore, this treatment must be administered under close medical supervision and in conjunction with other non-pharmacological approaches for children with ASD (e.g., behavioral therapy).”

Autism Data Science Initiative

HHS also announced recipients of the new Autism Data Science Initiative, with more than $50 million for 13 research projects on autism. The projects will use advanced methods, such as machine learning and organoid models, to address children and adults across the lifespan. Projects will include community engagement to align research with the needs of individuals diagnosed with autism, their families, and clinicians, according to the official announcement.