health
March 11, 2026
FDA contradicts Trump admin, declines to approve generic drug for autism
In the end, the FDA only approved the drug for a rare genetic condition with clearer data.
TL;DR
- The Trump administration claimed leucovorin was a promising treatment for autism, leading to increased prescriptions.
- The FDA has approved leucovorin for cerebral folate deficiency (CFD), a rare genetic condition, not for autism.
- FDA officials stated there was little evidence to support leucovorin's use for autism.
- A study that previously suggested leucovorin's benefit for autism was retracted due to errors.
- Leucovorin treats impaired folate metabolism, which can be a side effect of chemotherapy or due to genetic mutations causing CFD.
- CFD symptoms can resemble autism, but it affects a very small population.
- While some preliminary studies suggested leucovorin might help autism symptoms, findings are inconclusive.
- The presence of antibodies that block folate from the brain in some autistic individuals has been questioned as a cause, as non-autistic family members can also have them.
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