Earlier this month, Healthcare Innovation reported that the U.S. Department of Health and Human Services (HHS) was preparing to release a report indicating a potential connection between pregnant women’s use of pain medications and autism. Today, September 22, President Trump advised in the Oval Office alongside Health Secretary Robert F Kennedy Jr., that women avoid taking acetaminophen, known as Tylenol, throughout their pregnancy.
At the same time, the FDA announced it had initiated the process for a label change for acetaminophen, indicating that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions in children. The agency also issued a related letter alerting physicians nationwide.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, M.D., M.P.H., in a statement.
In a separate announcement, the FDA stated that it has initiated the approval process for leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects the transport of folate (a vitamin essential for brain health) into the brain. According to HHS, individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
Besides warning people about taking Tylenol during pregnancy, the Trump administration raised concerns about vaccines contributing to rising rates of autism, which affects 1 in 31 U.S. children today, according to the CDC, AP News’ Laura Ungar wrote. During the president’s announcement, NIH Director Jay Bhattacharya stated that the agency has initiated the Autism Data Science Initiative to “turbocharge” autism research, as reported by AP News’ Darlene Superville. Bhattacharya mentioned that millions of dollars will be allocated for data collection.
Rebecca Robbins reported for The New York Times that prior to President Trump’s remarks, Melissa Witt, a spokeswoman for Kenvue, the company behind Tylenol, made the following statement: “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.” Witt confirmed to The New York Times that Kenvue had “engaged in a scientific exchange with the secretary and members of his staff as it relates to the safety of our products.”
Josh Fischman with Scientific American noted that acetaminophen is safe and effective when used as directed. Robert F. Kennedy, Jr.’s statement that acetaminophen, when taken by a pregnant person, can cause autism in that person’s offspring runs counter to the most conclusive scientific evidence to date, Fischman wrote.
The American College of Obstetrics and Gynecology (ACOG) issued a statement by its president, Steven J. Fleischman, MD, MBA, FACOG, which stated, “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.” Furthermore, Fleischman stated, “the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.”
