White House Announces Controversial Changes to Drug Labels
Updated September 23, 2025 at 7:10 AM EDT
In a move sparking widespread debate, President Trump and key officials announced updates to drug labeling at a White House press conference on Monday, suggesting a possible association between acetaminophen use during pregnancy and autism.
The administration plans to revise the labels of acetaminophen, commonly known by the brand name Tylenol, to warn against its use by pregnant women. Additionally, they propose changing the label for leucovorin, a vitamin B derivative, to support its use for autism treatment. State Medicaid programs, in collaboration with the federal Centers for Medicare & Medicaid Services, will cover this new use despite limited supporting evidence.
This announcement is part of the administration’s broader initiative to explore the causes behind the rising autism diagnosis rates, though it lacks robust scientific backing. President Trump, joined by Health and Human Services Secretary Robert F. Kennedy Jr. and Dr. Mehmet Oz from the Centers for Medicare and Medicaid, strongly criticized the widespread use of acetaminophen, linking it to increasing autism rates.
President Trump stated, “Taking Tylenol is not good — I’ll say it: It’s not good,” and suggested, without evidence, that communities without access to the drug exhibit lower autism rates. He discouraged acetaminophen use in both pregnant women and infants, while also revisiting the debunked claim that vaccines might contribute to autism. Currently, an estimated 1 in 31 children in the U.S. are diagnosed with autism.
The administration’s guidance has faced criticism from medical professionals and organizations. In a statement to NPR, Tylenol’s manufacturer, Kenvue, challenged the administration’s assertions, stating, “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” and expressed concern over the potential confusion and health risks for expecting mothers.
Officials cited a study from Harvard University suggesting a slight increase in autism diagnoses among children of mothers who used acetaminophen during pregnancy. However, Ann Bauer, an epidemiologist involved in the study, cautioned that the government might be acting prematurely, noting that stronger evidence is needed before offering definitive guidance.
While autism diagnoses have surged over two decades, acetaminophen usage has remained consistent. The rise in diagnoses is often attributed to a broader definition of autism and increased awareness, explanations dismissed by Kennedy as a “canard.”
Medical and advocacy groups have expressed opposition to the administration’s stance. Steven J. Fleischman, M.D., president of the American College of Obstetricians and Gynecologists, criticized the lack of reliable data backing the announcement, calling it unsettling.
The Food and Drug Administration, in its notice to physicians, acknowledged the ongoing scientific debate, stating, “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 proposed use of leucovorin as an autism treatment has also faced skepticism, with the American Psychiatric Association emphasizing that it will take years of research to determine its efficacy for autism treatment.
President Trump admitted to imprecise language during the press conference, yet reiterated his advice against acetaminophen use, urging limited use if necessary. He also conflated vaccine and painkiller use, citing rumors and personal beliefs without substantiated evidence.
Medical experts, including those from the Society for Maternal-Fetal Medicine, have highlighted the potential risks of untreated fever during pregnancy and continue to recommend acetaminophen for managing fever and pain, noting that untreated fever can lead to severe complications.
Merck, known for producing vaccines for various diseases, refuted the claims of a vaccine-autism link, emphasizing decades of scientific studies disproving such associations.
Jackie Dilworth from The Arc of the United States criticized the announcement for potentially fueling stigma and misleading the public, calling it a distraction from real needs and support for affected families.
Copyright 2025 NPR
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