Ahead of an expected announcement from the Trump administration that Tylenol use in pregnancy is linked to an increased risk of autism in children, the drugmaker and medical experts are pushing back on the claims.
According to a report from the Washington Post, officials on Monday plan to tie autism to acetaminophen, the active ingredient in Tylenol, while also promoting a lesser-known drug called leucovorin, which is used as a treatment for some symptoms in children with autism. The Wall Street Journal previously reported the announcement was in the works, which the Department of Health and Human Services called “speculation” at the time.
On Sunday, Mr. Trump seemingly confirmed the plans, telling reporters “we’re going to do it tomorrow” when asked about the reports.
“I think it’s a very big factor. I think you’ll see what it is tomorrow. We have various things, but you’ll see what it is tomorrow,” the president said.
White House press secretary Karoline Leavitt said at a briefing Monday that she didn’t want to scoop Mr. Trump or HHS Secretary Robert F. Kennedy, Jr. on the announcement later today, but said, “They are paying attention to studies and the gold standard of science and research that many in this city for far too long have turned a blind eye to.”
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 Tylenol 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 said, “There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues.”
In a major study published last year, researchers followed nearly 2.5 million children in Sweden over 25 years and found acetaminophen use during pregnancy did not increase the risk of neurodevelopmental disorders in children.
The study, which used sibling comparisons to account for genetic factors, found no increase in risk of autism, ADHD or other intellectual disabilities when women used the medication during pregnancy.
“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.
In response to a question from CBS News’ Ed O’Keefe about whether the announcement could create confusion for pregnant women, Leavitt said women are confused about the chronic disease epidemic and “that’s exactly what this administration is focused on finding (answers for).”
“As a mother myself, I believe for many mothers across the country who really want answers to what is happening to our nation’s children,” she added.
What is leucovorin?
Leucovorin, an inexpensive, generic drug derived from folic acid (also known as folate or vitamin B9), is expected to be touted as an autism treatment in the administration’s announcement, the reports said. Leucovorin is currently prescribed 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.
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