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FDA finds little evidence Leucovorin helps autism
Government agency contradicts White House claims
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By Peter Clark (Senior Editor, Autism Info Center) Wednesday 18th March 2026 |
The Food and Drug Administration has officially approved a generic medication called Leucovorin for a very rare genetic condition, but the agency simultaneously distanced itself from previous claims made by the Trump administration.
In September 2025, officials had suggested the drug showed significant promise for treating autism symptoms.
However, senior FDA officials have now narrowed the scope of the approval, stating that the strongest evidence only supports the use of the drug for patients with a specific, ultra - rare mutation impacting folate delivery to the brain.
This condition is estimated to affect fewer than one in a million people in the United States.
Autism experts and researchers have expressed relief at the clarification, warning that there is no credible evidence to suggest Leucovorin is safe or effective for the general autistic population.
Some doctors had already begun prescribing the drug off - label following the earlier White House announcements, leading to supply shortages and reports of negative side effects like increased irritability and aggression in autistic children.
Source: WABE (USA)
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