Officials are recommending pregnant women avoid acetaminophen, unless they have high fevers.
Tylenol use in pregnancy is possibly associated with autism, and pregnant women should generally not take the drug unless they have serious fevers, federal officials said on Sept. 22.
The Food and Drug Administration notified doctors on Sept. 22 that using acetaminophen during pregnancy “may be associated with an increased risk of neurological conditions.”
Acetaminophen, the active ingredient of Tylenol, is a pain reliever. It is also available in generic drugs. About 60 percent of pregnant women are estimated to use acetaminophen.
Still, recognizing that there are no alternatives for pregnant women with high fevers, doctors should use their best judgment, officials said.
A spokesperson for Kenvue, parent company of Tylenol’s manufacturer, told The Epoch Times in an email: “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
Kenvue was spun off from Johnson & Johnson in 2023.
The American College of Obstetricians and Gynecologists is among the organizations that say acetaminophen is safe in pregnancy to deal with fever and headaches.
The rate of autism has jumped in the United States, rising to one in 31 8-year-olds in 2022, the most recent year for which data are available.
Multiple studies have found that acetaminophen use during pregnancy can increase the risk of autism, a disorder marked by symptoms such as difficulty communicating, difficulty processing change, and attention-deficit/hyperactivity disorder (ADHD), including a review of 46 prior studies published in August.
“Our findings show that higher-quality studies are more likely to show a link between prenatal acetaminophen exposure and increased risks of autism and ADHD,” Dr. Diddier Prada of the Icahn School of Medicine at Mount Sinai, one of the researchers, said in a statement when the review was released.
Some lawsuits have been filed alleging that retailers failed to warn people that Tylenol or generic versions of the drug could cause autism or ADHD. A federal judge in 2023, handling a number of those suits, determined that people proposed as expert witnesses by plaintiffs had not provided scientific evidence behind the claims and barred the people from testifying. Based on that order, the judge dismissed the cases.
Oral arguments in an appeal are slated to take place on Oct. 6.
