The FDA has issued a controversial acetaminophen pregnancy warning following announcements from the Trump administration linking prenatal use of the common pain reliever to increased autism risk in children. The September 22, 2025 announcement has sparked intense debate within the medical community, with major obstetric organizations pushing back against the claims.
FDA Commissioner Marty Makary released an open letter to physicians recommending they “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.” However, the letter also emphasized that acetaminophen remains “the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.”
Medical Community Responds to Acetaminophen Claims
The American College of Obstetricians and Gynecologists (ACOG) issued a strong statement opposing the administration’s position. ACOG President Dr. Steven J. Fleischman called the suggestions “highly concerning to clinicians” and “irresponsible when considering the harmful and confusing message they send to pregnant patients.”
According to ACOG, no reputable study has successfully concluded that acetaminophen use during pregnancy causes neurodevelopmental disorders. The organization pointed to two high-quality studies, including one published in JAMA, that found no significant associations between prenatal acetaminophen use and children’s risk of autism, ADHD, or intellectual disability.
Mount Sinai researchers recently published a study supporting potential links between prenatal acetaminophen exposure and neurodevelopmental disorders. However, the study’s authors emphasized that their findings do not prove acetaminophen directly causes these conditions and called for cautious, time-limited use under medical supervision.
Safety Concerns and Alternative Risks
Medical experts warn that President Trump’s suggestion for pregnant women to “tough it out” when experiencing fever could be more dangerous than taking acetaminophen. Dr. Lucky Sekhon, an OB/GYN specialist, noted that the “tough it out” messaging continues a problematic pattern in women’s healthcare.
Fevers during pregnancy, particularly in early stages, are associated with cardiac issues, cleft lip, cleft palate, and central nervous system abnormalities in developing babies. Untreated pain and fever can pose serious risks to both mother and child, making acetaminophen an important therapeutic option.
Kenvue, the maker of Tylenol, strongly disagreed with the administration’s position, stating that “independent, sound science clearly shows that taking acetaminophen does not cause autism.” The company emphasized that acetaminophen is the safest pain reliever option for pregnant women throughout their entire pregnancy.
The controversy has also raised concerns about potential increases in litigation against acetaminophen manufacturers. More than 500 related lawsuits were previously consolidated in federal court, though they were dismissed in August 2024 after a judge ruled the scientific evidence was insufficiently reliable.
As this debate continues, pregnant women are advised to consult with their healthcare providers about the safest approaches to managing pain and fever during pregnancy, weighing both potential risks and benefits of available treatments.