FDA Warns of Tylenol Autism Risk, Plans Label Update for Pain Reliever
In a Monday press conference, President Donald Trump announced that the U.S. Food and Drug Administration will send a letter warning doctors that Tylenol, officially known as acetaminophen, could be associated with an increased risk of autism. The FDA has also moved to update the popular pain reliever’s label with information on a potential autism connection.
“In recent years, evidence has accumulated suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children,” the letter to physicians, which is signed by FDA Commissioner Martin Makary, states. “Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth.”
The FDA cited multiple studies that it says suggest a correlation between Tylenol use during pregnancy and later diagnoses of autism and ADHD in impacted children.
Tylenol is currently the only over-the-counter drug that is approved to treat fevers during pregnancy.
Tylenol Maker Pushes Back on Claims of Autism Link
Kenvue, which makes Tylenol, combats claims that its drug could be linked to autism.
“We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism,” the company said in a statement earlier this month. “To date, the U.S. Food and Drug Administration (FDA) and leading medical organizations agree on the safety of acetaminophen, its use during pregnancy, and the information provided on the label.”
While the FDA is now planning a Tylenol label update, the agency has not gone as far as saying that pregnant women should never use the drug, noting that high fevers can be a serious risk to both pregnant women and unborn children. It also pointed out that the research on this topic is divided.
“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA’s letter to doctors stated. “… This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.”
FDA Announcement Comes as Tylenol Lawsuits Near Key Decision
The FDA’s new stance comes as Tylenol lawsuits filed over claims that the drug is tied to autism and ADHD approach a key juncture.
Those hundreds of cases were largely shut down after the judge overseeing the lawsuits barred key experts from testifying in 2023. The judge later granted summary judgment, ruling in favor of the defendants before the cases advanced to trial.
Next month, the 2nd U.S. Circuit Court of Appeals will hear oral arguments that could potentially revive Tylenol autism lawsuits.
It is unclear what impact, if any, the FDA’s latest announcements could have on that appeal process.
