"This week, the Trump administration announced that the FDA had approved leucovorin, a generic drug, as a treatment for autism. The announcement shocked health experts because the FDA's usual approval process, which is lengthy and rigorous, has been bypassed. Leucovorin, also known as folinic acid, is a derivative of vitamin B. It is typically used to counteract the harmful effects of methotrexate, a common chemotherapy drug."
"While a small number of studies have shown some improvement in children with autism who were treated with leucovorin, many autism researchers and advocates argue the announcement is premature and more research is needed. Current studies on high-dose leucovorin are very preliminary, says Danielle Hall, director of health equity at the Autism Society of America. Premature claims about its efficacy could lead to false hope and misinterpretation that leucovorin represents a cure', she warns."
"Leucovorin is very similar to folic acid, says Dr David Mandell, professor of psychiatry at the University of Pennsylvania Perelman School of Medicine. The difference is that leucovorin has been altered in a way that makes it easier to get through the blood-brain barrier for people who can't metabolize folic acid, he says. Folic acid is a synthetic form of folate, or vitamin B, a nutrient that helps the body make red blood cells and is essential for healthy cell growth and function,"
Leucovorin, a folinic acid derivative of vitamin B, received FDA approval for patients with cerebral folate deficiency (CFD). The approval announcement bypassed the FDA's usual lengthy review process, raising concern among health experts. Leucovorin is commonly used to counteract methotrexate toxicity. Small studies report some improvement in children with autism treated with leucovorin, but researchers and advocates caution that current evidence is preliminary and insufficient to claim efficacy. High-dose studies remain limited. Leucovorin resembles folic acid but is modified to cross the blood-brain barrier for individuals who cannot metabolize folic acid. Folate is essential for red blood cell production and fetal brain development.
Read at www.theguardian.com
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