The FDA will add a warning label to the over-the-counter medication.
DALLAS — President Donald Trump urged Americans not to take Tylenol while pregnant, and federal regulators are preparing to add a new warning label to the over-the-counter medication.
“I want to say it like it is. Don’t take Tylenol. Don’t take it,” Trump said repeatedly during remarks Monday from the White House.
Trump claimed the medication may cause autism.
“If you’re pregnant, don’t take Tylenol. And don’t give it to the baby after the baby is born,” he said.
The Food and Drug Administration announced it is beginning the process to put a warning label on bottles about potential risks associated with acetaminophen. Tylenol is the most widely recognized brand of acetaminophen.
Trump spoke alongside Health and Human Services Secretary Robert F. Kennedy, Jr., who spent many years promoting the debunked idea that vaccines cause autism.
Other members of the administration joined him, including FDA commissioner Martin Makary, who said his agency was also circulating a letter to doctors about potential risks of acetaminophen during pregnancy.
The letter, however, was less forceful than Trump’s statements.
Makary’s notice told doctors, “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.”
“In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers,” the letter continued. “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.”
Trump admitted he was speaking based on his own feelings.
“I’m not a doctor, but I’m giving my opinion,” Trump said.
Dr. Todd Ivey, a fellow with the American College of Obstetricians and Gynecologists and a practicing OBGYN in Houston since 1997, said statements linking Tylenol to autism are based on “flawed studies.”
“Nothing a parent does or doesn’t do causes autism,” Dr. Ivey said. “When you go back and look at some of the higher quality studies, there’s absolutely been no causal link that’s ever been proven between acetaminophen and any kind of neurodevelopmental disorder.”
Advocates in Texas also raised concerns about the White House messaging.
“I talk to moms every day, and this could be re-traumatizing,” said Adriana Crostley of the Autism Society of Texas. “Now we’re blaming the mom, saying because you took something during pregnancy, your kid now has autism.”
Her son Joshua, 18, has what she describes as profound autism.
“There was a time, especially when he was little, that I would stay up all night thinking, ‘Did I breastfeed him enough? Did I take something that was harmful for him? What could have I done?’” Crostley said.
The FDA also announced it has approved leucovorin, a prescription drug sometimes used alongside chemotherapy, as a treatment for autism.
Crostley says she has followed studies on leucovorin for years, and she worries the sample size is too small to move forward with approval.
“This moves us away from what we wanted to be talking about as families. Me, personally, I want to talk about services. I want to talk about early identification. I want to talk about community support,” she said. “Our families deserve leadership based in science, compassion, and transparency. That’s what we ask.”
Kenvue, the company that manufactures Tylenol, said in a statement that it “strongly disagrees” with the suggestion that Tylenol causes autism.
“The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism,” the statement said.
It also pointed out that untreated fever and pain are recognized as potential risks to pregnancy. Ivey urged people to rely on peer-reviewed science and clinical guidance.
“Let’s really hold on to the good evidence-based research out there,” he said. “And let’s listen to the physicians and the scientists and the healthcare providers that are doing this job.”
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