The Food and Drug Administration (FDA) will begin notifying physicians about a potential link between acetaminophen (name brand: Tylenol) use during pregnancy and autism, the White House announced Monday.
Speaking at the White House, President Trump said pregnant women should limit acetaminophen use unless medically necessary. “They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” he said from the White House floor.
The FDA, directed by Health Secretary Robert F. Kennedy Jr., has initiated a label change for Tylenol to note the possible risks of prenatal acetaminophen exposure and its unfounded link to autism and ADHD in children. Federal health officials emphasized that the move is based on association rather than causation.
The announcement follows a research review published in Environmental Health, which examined 46 studies on acetaminophen use during pregnancy. The review suggested a slight increase in risk for neurodevelopmental disorders in children exposed in utero but noted that the evidence does not prove a causal link. A large 2024 Swedish study of 2.5 million children also found that associations disappeared when sibling controls were analyzed (JAMA, 2024).
Does Tylenol Use in Pregnancy Cause Autism? Health Experts Weigh In
Medical experts swiftly criticized the administration’s claims. Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said the announcement “dangerously simplifies the many and complex causes of neurologic challenges in children” and is “not backed by the full body of scientific evidence.” He went on to state more clearly, “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.”
Dr. Danelle Fisher, a pediatrician at Providence Saint John’s Health Center in Santa Monica, Calif., said the review shows only an association. “An association may be present between pregnant women who eat ice cream during pregnancy and have a child with autism,” Fisher said. “Does the eating of ice cream cause autism? No, but since it occurred during pregnancy, one could posit an association. There is no proof that acetaminophen causes autism, period,” she continued.
Kenvue, the maker of Tylenol, disputed the claims. “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” the company said.
Leucovorin, a form of folate, is being explored as a potential treatment for autism in children with folate deficiency. FDA Commissioner Marty Makary said the drug may help improve verbal communication, but researchers caution that evidence is preliminary and further study is needed to substantiate the claim.
HHS Director Kennedy has pointed to an increase in autism diagnoses over the last several decades as proof of a link; however, the scientific community challenges the claim. Autism diagnoses have risen in recent decades, but experts attribute much of the increase to expanded diagnostic criteria, heightened awareness, and broader screening in a CDC study from 2020. Health officials say acetaminophen remains the only safe over-the-counter pain reliever recommended for pregnant women, and untreated fever carries significant risks, including birth defects and miscarriage.
Public health organizations and autism advocacy groups warned that the administration’s statements could cause confusion and unnecessary alarm. Jackie Dilworth of The Arc of the United States called the claims “irresponsible” and said they could mislead families and stigmatize autistic individuals.
NJ Joins Health Alliance With Northeast U.S. States
New Jersey recently joined a new public health coalition called the Northeast Public Health Collaborative along with states such as New York and Pennsylvania. The coalition will make their own vaccine recommendations as a response recent changes to federal vaccine policy. Though focused primarily on vaccines, the coalition could potentially create responses to other changes in federal health policy. The Northeast Public Health Collaborative has yet to respond to the recent Tylenol-autism link from the White House.
The New Jersey Digest is a new jersey magazine that has chronicled daily life in the Garden State for over 10 years.