Acetaminophen remains the most widely recommended pain reliever during pregnancy, according to the American College of Obstetricians and Gynecologists (ACOG) and other major medical groups.
Studies have explored possible associations between acetaminophen exposure in utero and neurodevelopmental conditions such as autism or ADHD. However, the consensus remains clear: no published study has established a causal link.
An April 2024 NIH-funded study published in JAMA concluded that acetaminophen use in pregnancy was not linked to increased risks of autism, ADHD, or intellectual disability.
The FDA itself released a more cautious notice to clinicians on Monday evening, stating:
“While an association between acetaminophen and autism has been described in some studies, a causal relationship has not been established. Clinicians should be aware of the ongoing debate.”
Mixed Findings and Ongoing Research
Federal officials referenced an August 2025 meta-analysis from researchers at Mt. Sinai, Harvard, UCLA, and UMass Lowell, which suggested prenatal acetaminophen exposure may raise risks for neurodevelopmental disorders. The authors, however, emphasized that their findings do not prove causation and stopped short of recommending pregnant patients avoid acetaminophen.
“Acetaminophen remains an important tool for pregnant patients and their physicians,” said Dr. Andrea Baccarelli of Harvard T.H. Chan School of Public Health, a co-author of the study. “High fever can itself pose risks to both mother and fetus.”
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Medical Experts Warn of Public Confusion
Health leaders expressed concern that the administration’s rhetoric could discourage women from treating potentially dangerous conditions such as high fever.
“Acetaminophen is still the safest option we have during pregnancy,” said Boston University autism researcher Helen Tager-Flusberg. “Announcing complex findings without context risks unnecessary alarm.”
The maker of Tylenol, Kenvue, issued a statement rejecting the administration’s claims:
“We strongly disagree with any suggestion that acetaminophen causes autism. Without safe pain relief, pregnant women face harmful alternatives or untreated conditions.”
Autism Rates and Broader Debate
CDC data show that autism diagnoses among U.S. 8-year-olds rose to 1 in 31 in 2022, compared to 1 in 36 in 2020 and 1 in 150 in 2000. Experts largely attribute this increase to improved awareness, expanded diagnostic criteria, and better access to services, not to a single environmental factor.
Despite this, President Trump and Health and Human Services Secretary Robert F. Kennedy Jr. have suggested both acetaminophen and vaccines should be scrutinized, positions that contradict years of research showing no link between vaccines and autism.
Looking Ahead
The FDA confirmed it will begin reviewing acetaminophen labeling for potential updates. Meanwhile, administration officials also signaled plans to accelerate the approval process for leucovorin, a drug under study for limited use in autism treatment, though experts cautioned that current evidence remains preliminary.
Medical groups urged pregnant women to continue following physician guidance. “The priority remains managing maternal health and preventing risks like untreated fever,” ACOG noted.
