President Trump announced the Food and Drug Administration believes the use of acetaminophen — the active ingredient in Tylenol and many cold and flu medications — during pregnancy can be associated with an increased risk of autism, though medical experts have said the medication is safe.
“Effective immediately, the FDA will be notifying physicians that the use of acetaminophen during pregnancy can be associated with a very increased risk of autism,” the president said. “So, taking Tylenol is not good, alright? I’ll say it. It’s not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.”
“Ideally, a woman won’t take Tylenol,” he said, and pivoted to discussion of childhood vaccination, saying vaccines should be given in “smaller doses” and spread out “over a period of years,” without citing medical evidence for his claims about vaccines. On his various vaccine recommendations, the president said, “You know, I’m just making these statements from me, I’m not making them from these doctors.”
Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA based its decision on acetaminophen on “clinical and laboratory studies” that “suggest a potential association between acetaminophen used during pregnancy and adverse neurodevelopmental outcomes,” including one study in the public health journal Environmental Health, but added that “NIH [National Institutes of Health] research teams are currently testing multiple hypotheses.”
However, in a major study published last year, researchers followed nearly 2.5 million children in Sweden over 25 years and found that acetaminophen use during pregnancy did not increase the risk of neurodevelopmental disorders in children.
After Mr. Trump’s announcement, the FDA shared an open letter encouraging physicians to “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers” — though the agency was more cautious than some of the president’s statements.
“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 letter states, calling the issue an “ongoing area of scientific debate.”
The letter also stated physicians should balance the possible risks of acetaminophen with the fact that it is still safer than other over-the-counter painkillers and fever-reducing drugs during pregnancy, like aspirin and ibuprofen.
The announcement comes after Kennedy said in April that HHS would undertake a “massive testing and research effort” to determine the cause of autism. Kennedy at the time said the plan was to release a comprehensive report in September. However, National Institutes of Health Director Dr. Jay Bhattacharya said later that month it could be as long as a year before the findings are released.
“To meet the president’s challenge, I ordered HHS to launch unprecedented, all-agency effort to identify all causes of autism, including toxic and pharmaceutical exposures,” Kennedy said.
FDA Commissioner Marty Makary also announced FDA approval of the drug leucovorin to treat autism in children. It has previously been used off-label for that purpose.
Autism has become more prevalent in children born in the U.S. over the past 25 years, according to statistics compiled by the U.S. Centers for Disease Control and Prevention. But there is no scientific consensus on the reasons why. Most experts say it is likely due to a combination of factors, including changes in the way the condition is diagnosed.
Tylenol maker responds to autism claims
In a statement to CBS News, Kenvue, the maker of Tylenol, said “independent, sound science clearly shows that taking acetaminophen does not cause autism.”
“We strongly disagree with any suggestion otherwise,” the statement continues, highlighting what the company says is the greater health risk for expecting mothers from other conditions if they give up on taking the drug. “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
“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 company said, adding that it “will continue to explore all options to protect the health interests of American women and children.”
Medical experts on acetaminophen and autism research
In a statement to CBS News when reports of the administration’s plans first surfaced, the American College of Obstetricians and Gynecologists (ACOG) said, “There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues.”
Following the administration’s announcement Monday, ACOG President Dr. Steven J. Fleischman said in a statement: “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy.”
“Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children,” Fleischman said. “It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.”
“The best evidence does not show an association between Tylenol and autism,” said Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News. “The medical community, the scientific community has the same consensus, which is that Tylenol, acetaminophen, is safe in pregnancy.”
Gounder said acetaminophen is considered the safest option for treating issues like pain and high fever during pregnancy.
“If you have a high fever during pregnancy, that can cause neurodevelopment issues in the baby, so you don’t want to let that fever go untreated,” Gounder explained, adding she’s worried that expectant mothers may turn to other options that would be less safe.
“Will women end up taking other medications like aspirin or ibuprofen during pregnancy? Those actually can be dangerous, especially in the third trimester, you can end up with kidney issues, cardiac issues in the baby,” she said.
While some previous research suggested there could be a possible association between acetaminophen use and neurodevelopmental disorders, those studies involved relatively small groups and did not prove a link. Larger and more robust studies have found no connection.
“Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature given the current science,” the Autism Science Foundation said in a statement.
The Consumer Healthcare Products Association, which represents some of the largest makers of over-the-counter medications, including acetaminophen, said, “Safety is the top priority for manufacturers,” and “the well-established profile of acetaminophen is supported by decades of research and real-world use.”
“Scientific and medical authorities around the world recognize acetaminophen as the only analgesic considered safe for use during pregnancy when used according to the Drug Facts label, which specifically reminds pregnant women to always consult their healthcare provider before use,” the group said.
What is leucovorin?
FDA Commissioner Marty Makary said autism “may also be due to an autoimmune reaction to a folate receptor on the brain not allowing that important vitamin to get into the brain cells.”
He announced FDA approval of the drug leucovorin, which is derived from folic acid (also known as folate or vitamin B9), to treat autism in children. Leucovorin is an inexpensive, generic drug that was previously approved to ease the side effects of cancer chemotherapy.
Pregnant women are prescribed multivitamins with folic acid to prevent neural tube defects. The neural tube develops into the brain and spinal cord.
Specialists say leucovorin can be helpful in treating some autism cases, but it is not a universal remedy.
“You can have a perfectly normal folate level in your blood, but it may not be getting into the brain, and so there’s a defect in the transport of folate into the brain. Leucovorin works around that,” Gounder explained. “Not all children with autism have this defect, so there’s a test you can do to assess whether that’s what’s at play. For those kids, leucovorin has been shown to help, particularly with speech, getting kids to be more verbal than they were before.”
Leucovorin isn’t a cure for autism, but “it could really have a substantial impact on a very good percentage of children with autism,” Dr. Richard Frye, a pediatric neurologist, told CBS News earlier this year.