"President Donald Trump said Monday the Food and Drug Administration approved a chemotherapy drug called leucovorin as a treatment to alleviate symptoms of autism, despite little evidence that the medication works. Trump also said the administration is issuing a warning to doctors not to recommend acetaminophen - the active ingredient in Tylenol and other widely used medications - for pregnant women, claiming it may be linked to autism in children."
"Leucovorin is a drug approved by the FDA to counteract the side effects of certain chemotherapy drugs and sometimes used off-label to treat vitamin B9 deficiency. Leucovorin is a form of folinic acid, a B vitamin. The drug has shown promise in clinical trials with helping some children with autism improve their speech. But the Autism Science Foundation, which funds evidence-based autism research, does not recommend it as a treatment yet and says more studies are needed."
FDA updated leucovorin's label to include treatment of autism symptoms despite limited high-quality evidence of benefit. Leucovorin is approved to counteract chemotherapy side effects and is sometimes used off-label to treat folinic acid (vitamin B9) deficiency. Some clinical trials reported speech improvements for certain children with autism, but major autism research organizations do not recommend routine use without further study. A government warning advised against acetaminophen use during pregnancy over concerns about a possible autism link. Medicaid, in partnership with states, will cover leucovorin for this indication under public insurance.
Read at TODAY.com
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