Washington, D.C. – September 23, 2025 — The U.S. Food and Drug Administration (FDA) announced today that it has initiated the process for updating the labeling of acetaminophen-containing products, such as Tylenol. This update reflects mounting scientific evidence that links prenatal use of the drug to an increased risk of neurological disorders. These include autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in children. The FDA responds to evidence of Tylenol risks responsibly, ensuring public safety.
In a statement, FDA Commissioner Marty Makary, M.D., M.P.H., said:
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Our goal is to ensure that patients and healthcare professionals are equipped with the most up-to-date information to guide safe decision-making during pregnancy.”
The move comes amid growing concerns among scientists and healthcare providers about the safety of using acetaminophen during pregnancy. In recent years, several large-scale cohort studies—including the Nurses’ Health Study II and the Boston Birth Cohort—have reported a statistical association between maternal acetaminophen use and an elevated risk of developmental conditions in offspring. This evidence has led to the FDA’s rigorous response regarding Tylenol use during pregnancy.
While these studies do not establish a definitive causal relationship, their findings have prompted renewed scrutiny of a medication long considered safe for use during pregnancy.
Acetaminophen, commonly used to relieve pain and reduce fever, is one of the most widely used medications in the United States. This includes among pregnant individuals. The FDA emphasized that it is not advising immediate cessation of acetaminophen use during pregnancy. Instead, they advocate for a more cautious and informed approach. They have responded to mounting evidence of Tylenol risks with this precautionary measure.
The agency is expected to work closely with manufacturers to revise product labeling. The update will likely include a warning about the potential risks. It encourages pregnant individuals to consult healthcare providers before using the medication, especially for prolonged periods or at high doses.
Public health experts have noted that while the potential risks are concerning, the absolute risk increase remains relatively small. Still, they stress the importance of balancing pain management needs during pregnancy with emerging safety data.
The FDA’s decision aligns with its broader mission to protect public health. They ensure the safety, efficacy, and security of drugs, vaccines, medical devices, and other biological products. The agency stated that it will continue to monitor new research and may take additional regulatory steps as more data become available. They will respond consistently to evidence about Tylenol’s safety for use during pregnancy.
Healthcare professionals are advised to stay informed on the upcoming label changes. They should discuss the evolving evidence with patients who are pregnant or planning to become pregnant. They should consider recent updates as the FDA responds to such significant evidence.
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