Trump Admin Says Evidence Suggests Tylenol Use in Pregnancy Linked to Autism – The Epoch Times

Tylenol-brand pain relief medicine on display at a store in Prescott, Arizona (ideogram.io)

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.

Lawsuits Claiming Tylenol Causes Autism Lack Scientific Support, Judge Finds

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.

Sending Notice, Updating Label

The FDA’s letter told doctors that “an association between acetaminophen and autism has been described in many studies.”

“We now have data we cannot ignore,” FDA Commissioner Dr. Marty Makary said during a Sept. 22 news briefing.

That includes a 2019 paper from U.S. researchers who analyzed cord plasma.

The researchers said they found evidence that babies exposed to acetaminophen in the womb had a significantly increased risk of developing autism or ADHD.

Some other research has found no evidence supporting a link between fetal exposure to acetaminophen and autism, including a 2024 analysis of nearly 2.5 million Swedish children.

Makary said in the letter that “a causal relationship has not been established and there are contrary studies in the scientific literature.”

The notice says doctors should consider minimizing the use of acetaminophen during pregnancy for routine, low-grade fevers, but it describes acetaminophen as the safest over-the-counter option in pregnancy for fevers.

The FDA is also initiating a labeling change for acetaminophen to provide updated information about the link between acetaminophen and autism.

The Food and Drug Administration states on its website on a page last updated in August that “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.” Regulators said they advise consulting with doctors before using any medicine during pregnancy.

Autism Treatment

Officials also said on Sept. 22 that there are enough data suggesting that a medication called leucovorin, approved for several uses, including treating colorectal cancer, can help treat autism.

Folinic acid and folic acid are forms of vitamin B9. People without enough folic acid or folinic acid are deficient in folate, which is required for body functions such as producing red blood cells.

Some research has concluded that autistic children have high levels of folate receptor autoantibodies, which interfere with the transport of folate, or vitamin B9, in the body.

Dr. Richard E. Frye ran a trial testing folinic acid in autistic children. The recipients experienced improvements in verbal communication, Frye and coauthors reported in 2016.

“I think this is a major step forward to get many children with autism treated and improve their ability to function. It is particularly groundbreaking in the fact that many do not think that autism can be treated at its core. This treatment fixes core biological deficits and therefore could be disease modifying,” Frye told The Epoch Times in an email.

“Recognition by the administration that there is such a treatment gives hope to many families.”

The Autism Science Foundation, a group that supports autism research, said in a recent statement that the science regarding folinic acid and autism “is still in very early stages, and more studies are necessary before a definitive conclusion can be reached.”