Trump administration to warn Tylenol may be linked to autism; leucovorin touted as potential treatment

The Trump administration is preparing to warn that acetaminophen, the active ingredient in Tylenol, may be linked to autism when used early in pregnancy, as part of a broader federal review into rising autism rates. Officials also are expected to highlight leucovorin, a inexpensive medication, as a possible treatment for some autism symptoms. The push comes as health secretary Robert F. Kennedy Jr. leads an administration effort to probe environmental factors and other potential causes behind a sustained increase in autism diagnoses across the United States.

The guidance reportedly would urge pregnant women to avoid Tylenol unless they have a fever or other pressing medical need, a position that officials say reflects caution in light of a review examining what is driving higher autism rates. President Trump teased the announcement at a recent event, telling attendees that it would be “very important” and “one of the most important things that we will do.” White House spokesperson Kush Desai said the announcements would be pursued with “Gold Standard Science.”

In parallel with the Tylenol warning, officials plan to introduce leucovorin as a potential autism treatment on Monday. Leucovorin is a form of folate used to support healthy cells and is already approved in the United States to protect bone marrow during chemotherapy. Doctors can prescribe it off label for other conditions, and proponents say it is a low-cost option—about $2.50 per pill—that could improve communication and other behaviors in some autistic patients. However, NHS- or FDA-approved evidence specific to autism remains limited, and experts caution that leucovorin is not a cure and would likely be part of a broader treatment plan.

Leucovorin’s off-label use in autism has been championed by a small number of clinicians. Dr. Richard Frye, a pediatric neurologist who has treated autistic children in Arizona, has described notable improvements in some previously nonverbal patients after starting leucovorin. He and others emphasize that many patients would still require standard therapies, including speech and behavioral therapies, alongside any pharmacological approach. Frye notes that leucovorin is cheaper than many existing interventions and could lessen the intensity or duration of other treatments for some children, though the drug is not yet FDA-approved specifically for autism. In the United States, about 50 doctors are known to prescribe it for autism, reflecting cautious adoption pending formal approvals and more robust studies.

The medical community has long discussed folate’s role in brain development, and some studies have suggested that insufficient folate supply may contribute to certain developmental delays in a subset of autistic children. Proponents of leucovorin argue that because folate plays a crucial role in neural development, leveraging this pathway could improve communication and behavior for some patients. Critics caution that while early folate intake during pregnancy reduces certain birth defects, extrapolating those benefits to autism remains controversial and requires rigorous clinical trials. Leucovorin’s safety profile is well-established for its approved uses, but its autism-specific effectiveness remains under investigation. If used in autism, it would generally be in combination with other therapies, rather than as a stand-alone solution.

The broader context involves rapidly shifting estimates of autism prevalence. By some measures, about one in 31 children in the United States would be diagnosed with autism as of April 2025, up from roughly one in 150 children in 2000. The rising numbers have sparked debates about whether better detection and diagnostic practices account for the increase or whether environmental or other factors contribute. RFK Jr has publicly suggested that environmental toxins, including food, pesticides, and vaccines, could play a role and has pledged to pursue investigations in those areas as part of the administration’s autism agenda.

Several government agencies are contributing to the broader effort. The National Institutes of Health is expected to announce Monday that a new autism data science initiative has begun. The program funds 13 research teams focused on identifying causes and treatments for autism and on validating prior findings. Officials say the initiative is separate from the administration’s ongoing review of autism research, and Bhattacharya, an NIH official, noted that the review will be conducted in depth and undergo official review before any final conclusions are released. The NIH plan aims to accelerate data-driven discovery while maintaining rigorous standards for evidence.

The White House has stressed that the approach to autism will rely on “Gold Standard Science” and transparent evaluation of evidence. Critics, meanwhile, caution against drawing premature conclusions about the Tylenol-autism link without robust epidemiological and clinical data. The administration’s stated goal is to address rising autism rates while ensuring patient safety and avoiding overreach in public health messaging.

The Daily Mail, which has published parts of this reporting, notes that the proposals reflect a broader strategy to pair cautious preventive guidance with promising, accessible treatment options. While the overarching narrative centers on improving outcomes for autistic individuals and their families, officials emphasize that any potential connections between acetaminophen use in pregnancy and autism would require careful verification through peer-reviewed research and official guidance before widespread policy changes are implemented. The situation remains fluid as agencies review existing studies, commission new research, and prepare to present findings to the public in the coming days.

In summary, the administration is moving to publicly address autism through a two-pronged approach: a precautionary stance on a widely used medication during pregnancy, and a hopeful look at a low-cost, readily available treatment that could complement established therapies. The process underscores the evolving nature of autism research, the need for rigorous validation, and the ongoing effort to balance safety, efficacy, and accessibility in the care of individuals with autism.