FDA Considers Leucovorin Label Change for Children with Folate Deficiency
The FDA is evaluating a leucovorin label change to aid children with folate deficiency, potentially linked to autism, despite limited evidence and Trump administration backing.
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Overview
- The FDA is currently reviewing a proposal to modify the label for the drug leucovorin, aiming to expand its approved uses for pediatric patients.
- This potential label change specifically targets children diagnosed with folate deficiency, a nutritional condition that can have various health implications for development.
- The expanded use of leucovorin is being considered due to a potential, though not fully established, link between folate deficiency and autism spectrum disorders in children.
- Despite the ongoing discussions, the scientific evidence supporting a direct connection between folate deficiency, autism, and leucovorin's efficacy in this context remains limited.
- The initiative to re-evaluate leucovorin's labeling has received support and backing from the Trump administration, influencing the FDA's current review process.
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FAQ
Leucovorin, also known as folinic acid, is a generic drug primarily used for cancer treatment and certain forms of anemia.
The FDA is considering the label change to approve leucovorin for children with cerebral folate deficiency and related autism symptoms, based on research suggesting it may improve verbal communication in some affected children.
Evidence is limited but suggests that leucovorin may help improve verbal communication in children with cerebral folate deficiency and autism symptoms, though it is not a cure for autism.
The Trump administration has supported and backed the initiative to re-evaluate leucovorin's labeling for this new use, influencing the FDA's current review process.
Once FDA approval is granted for this new use, Medicaid and the Children’s Health Insurance Program (CHIP) will be required to cover leucovorin nationwide, potentially benefiting over half of all U.S. children.
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