What to know about the White House's Tylenol and autism announcement
President Donald Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. on Monday highlighted a possible link between autism and the use of acetaminophen, the active ingredient in Tylenol, in pregnant women.
They also announced that leucovorin calcium, a form of folic acid, or vitamin B9, currently used to help cancer patients with the side effects of chemotherapy, will become available to some children who have cerebral folate deficiency, a condition in which people can show "developmental delays with autistic features," according to HHS.
What is known about the possible link between acetaminophen (Tylenol) and autism?
Last month, researchers from prestigious institutions published a paper that reviewed 43 studies on the association between pregnant women who used acetaminophen and those who had children diagnosed with neurodevelopmental disorders. They found 27 of the studies showed significant links between the two. But, the authors wrote, no direct cause and effect could be determined.
It called the analyses "evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence" of autism and ADHD. The researchers said pregnant women should be advised to limit use of acetaminophen.
Other research hasn't found a link between acetaminophen and autism.
Acetaminophen has long been considered the safest of the over-the-counter pain medicines during pregnancies, though doctors have cautioned patients to try to minimize the amount used.
What action will the federal government take?
The FDA on Monday sent a letter to physicians that took a much more measured tone than the news conference by Trump and administration officials.
That letter said "evidence has accumulated" suggesting the link between acetaminophen and autism and attention-deficit/hyperactivity disorder, but also noted there are contrary studies and it an "ongoing area of scientific debate."
The letter, signed by FDA Commissioner Dr. Martin Makary, said doctors should consider minimizing the use of Tylenol during pregnancy for routine low-grade fevers. It also called it "the safest over-the-counter alternative" in pregnancy, given aspirin and ibuprofen's well-documented impacts on fetuses.
Trump administration officials also said they were working on additional safety language for products that contain acetaminophen, like Tylenol.
What should pregnant women with fevers do?
There are no safer alternatives to address pain or fever in pregnant women, said Dr. Dawnette Lewis, an OB/GYN and director of Northwell Health’s Center for Maternal Health. She said women should still take acetaminophen to bring down their fever.
Not treating a fever while pregnant can lead to problems for both the pregnant mother and her developing baby, such as sepsis or a kidney infection, Lewis said.
"If the mother’s temperature is high, the temperature in the uterus also rises, which can be harmful to the baby," she said in an interview.
Lewis urged pregnant women to discuss these issues with their health care providers.
What do we know about the autism treatment?
On Monday, FDA officials said they were starting the process of approving leucovorin calcium tablets for people with cerebral folate deficiency, a condition that prevents the correct amounts of folate from getting to a person’s brain. Some people with CFD have sensory processing, repetitive behaviors and challenges with social communication, similar to people with autism.
The agency said it analyzed literature published between 2009 and 2024 and determined the drug can help people with CFD.
There is currently no medical treatment for autism. Children with autism spectrum disorders often receive specialized therapy and education designed for their individual needs.
Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.
