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Leucovorin

All articles tagged with #leucovorin

Media Frenzy Triggers 2,000% Surge in Leucovorin Use for Autism
health7 days ago

Media Frenzy Triggers 2,000% Surge in Leucovorin Use for Autism

A UCSD study using the Epic Cosmos database found leucovorin prescriptions for children with autism rose more than 2,000% after a February 2025 TV segment and subsequent September 2025 White House promotion, despite no proven autism benefit; the FDA later approved leucovorin only for cerebral folate transport deficiency in March 2026. The study highlights how media coverage and political messaging can rapidly shift off-label prescribing before large, definitive trials exist, and it does not assess patient outcomes.

via Neuroscience News|
#autism#health#leucovorin
Presidential Endorsements Drive Spike in Unproven Autism Drug
health8 days ago

Presidential Endorsements Drive Spike in Unproven Autism Drug

A UCSD study finds leucovorin prescriptions for children with autism surged over 2,000% after public statements by Trump and RFK Jr., fueled by media reports despite weak evidence of benefit for autism. The FDA has approved leucovorin only for cerebral folate deficiency, not autism, and researchers urge long-term, rigorous studies to understand outcomes for families who pursued the treatment.

via Gizmodo|
#autism#donald-trump#health
FDA approves leucovorin for ultra-rare CFD-FOLR1 subset without trial
health2 months ago

FDA approves leucovorin for ultra-rare CFD-FOLR1 subset without trial

The FDA updated the leucovorin label to treat cerebral folate deficiency caused by FOLR1 mutations (CFD-FOLR1), a ultrarare condition linked to autism features, approving the drug based on published case reports and mechanistic rationale rather than a randomized trial. The decision narrows the target population to CFD-FOLR1 after reviewers found the highest-quality data in this subgroup; the move relies on real-world evidence and a plausible mechanism pathway. GSK will stop manufacturing Wellcovorin, but generics exist and importation is allowed; broader autism use remains controversial and calls for more research.

via Fierce Pharma|
#cfd-folr1#fda#health
FDA keeps leucovorin for a rare condition, not autism
health-policy2 months ago

FDA keeps leucovorin for a rare condition, not autism

The FDA said leucovorin will be approved only for cerebral folate deficiency (CFD-FOLR1) and will not be expanded to autism, despite the Trump administration’s push. Regulators cited limited evidence for autism treatment and noted a retraction of a key study, narrowing the review to the rare CFD-FOLR1 condition and highlighting the gap between political claims and scientific proof for autism therapies.

via Ars Technica|
#autism#cfd-folr1#fda
FDA narrows leucovorin's promise: approved for cerebral folate deficiency, not autism
health2 months ago

FDA narrows leucovorin's promise: approved for cerebral folate deficiency, not autism

The FDA approved leucovorin only for cerebral folate deficiency caused by pathogenic FOLR1 variants, not as a treatment for autism, despite earlier pitches by officials that it could help many autistic children. The supporting evidence for autism benefit has been weak and a major trial was retracted due to data concerns. The rare genetic form this approval covers affects a small number of cases, and the agency is encouraging more research to assess any broader autism effects while signaling the treatment’s utility remains limited to the specific cerebral folate deficiency condition.

via Gizmodo|
#autism#cerebral-folate-deficiency#fda-approval
health2 months ago

FDA scales back autism hype as leucovorin gains rare-disease approval

FDA officials say there’s insufficient data to approve leucovorin for autism, reversing earlier optimism from RFK Jr. and FDA Commissioner Makary; the drug is now approved for a rare CFD-FOLR1–related cerebral folate deficiency, with off-label autism use left to physician discussion and future research; the initial trial cited in support of autism benefits was retracted, underscoring data limitations.

via Politico|
#autism#cerebral-folate-deficiency#fda
FDA approves leucovorin for cerebral folate deficiency in rare patients
health2 months ago

FDA approves leucovorin for cerebral folate deficiency in rare patients

The FDA approved leucovorin (folinic acid) as the first treatment for cerebral folate deficiency—a rare genetic disorder that prevents folate from reaching the brain—in select adults and children. The decision was based on a systematic review of published case data rather than a randomized trial and did not establish broad efficacy for autism, though future autism studies remain possible. The approval covers generic leucovorin and GSK’s Wellcovorin, and regulators urged manufacturers to boost production to meet rising demand; GSK has no plans to relaunch the product.

via CNBC|
#autism#cerebral-folate-deficiency#fda-approval
Leucovorin: The Autism Treatment Approved Amidst Controversy
health8 months ago

Leucovorin: The Autism Treatment Approved Amidst Controversy

Families have been using leucovorin, a drug originally for cancer, to treat autism symptoms, gaining attention after President Trump mentioned it. While some studies suggest potential benefits, the evidence is limited and the FDA's recent move to update the drug's label is considered unusual and controversial due to weak supporting data. Experts emphasize the need for more research and caution in its use.

via NBC News|
#autism#cerebral-folate-deficiency#fda