In a surprising announcement, President Trump stated that the Food and Drug Administration (FDA) believes there may be a link between the use of acetaminophen, the active ingredient in Tylenol, during pregnancy and an increased risk of autism in children. This claim has sparked significant debate, as many medical professionals assert that acetaminophen is safe for use during pregnancy.
“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,” Trump proclaimed. He emphasized, “So, taking Tylenol is not good, alright? I’ll say it. It’s not good.” The president urged women to limit their use of Tylenol during pregnancy unless it is medically necessary.
In his comments, Trump also veered off into discussions about childhood vaccinations, recommending that vaccines be administered in “smaller doses” over an extended period. However, he did not provide any scientific evidence to support his assertions regarding vaccines, stating, “You know, I’m just making these statements from me, I’m not making them from these doctors.”
Robert F. Kennedy Jr. echoed Trump’s sentiments, asserting that the FDA’s conclusions about acetaminophen are based on “clinical and laboratory studies” suggesting a potential link between its use during pregnancy and adverse neurodevelopmental outcomes. He cited a study published in the journal Environmental Health but acknowledged that research from the National Institutes of Health (NIH) is ongoing.
Contradicting the president’s claims, a major study released last year followed almost 2.5 million children in Sweden over 25 years, concluding that acetaminophen use during pregnancy did not heighten the risk of neurodevelopmental disorders in children.
This announcement follows Kennedy’s earlier statements in April, where he indicated that the Department of Health and Human Services (HHS) would launch a “massive testing and research effort” to investigate the causes of autism, with a comprehensive report expected in September. However, NIH Director Dr. Jay Bhattacharya later stated that findings could take up to a year to release.
The prevalence of autism in U.S. children has risen significantly over the past 25 years, according to data from the Centers for Disease Control and Prevention (CDC). While the reasons for this increase remain unclear, experts generally agree that it is likely due to a combination of factors, including changes in diagnostic practices.
In response to the controversy, Kenvue, the manufacturer of Tylenol, issued a statement emphasizing that “independent, sound science clearly shows that taking acetaminophen does not cause autism.” The company strongly disagreed with any claims suggesting otherwise, highlighting the potential health risks for pregnant women who avoid acetaminophen. “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” the statement read. Kenvue underscored that a decade of rigorous research supports the safety of acetaminophen, asserting that they would continue to prioritize the health of American women and children.
Medical experts have also weighed in on the issue. The American College of Obstetricians and Gynecologists stated that “there is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues.” Dr. Céline Gounder, a medical contributor for CBS News, reiterated that the consensus within the medical community is that acetaminophen is safe to use during pregnancy. She expressed concern that expectant mothers might resort to less safe alternatives if they are discouraged from using Tylenol.
While some earlier studies suggested a possible link between acetaminophen and neurodevelopmental disorders, those studies often involved small sample sizes and failed to establish a definitive connection. More extensive research has consistently found no correlation between the two.
The Autism Science Foundation issued a statement declaring that any association between acetaminophen and autism is based on limited and inconsistent science, deeming it premature to draw conclusions at this stage. The Consumer Healthcare Products Association, which represents leading manufacturers of over-the-counter medications, reiterated that safety is their top priority and that acetaminophen’s safety profile is supported by decades of research and real-world usage.
In a separate announcement, the FDA also approved a drug called leucovorin for the treatment of autism. Leucovorin, derived from folic acid, was previously approved to mitigate the side effects of chemotherapy. It is often prescribed to pregnant women as a multivitamin to prevent neural tube defects, which can affect brain and spinal cord development.
While specialists indicate that leucovorin may benefit some children with autism, it is not a universal solution. Dr. Gounder explained that while some children may have normal folate levels in their blood, they may not effectively transport it to the brain. Leucovorin can help address this issue and has shown promise, particularly in improving speech in affected children.
Although leucovorin is not a cure for autism, Dr. Richard Frye, a pediatric neurologist, noted that it could significantly impact a notable percentage of children with autism. As the discourse around autism and its treatments continues to evolve, it remains crucial for medical professionals and the public to rely on sound scientific evidence rather than unverified claims.
