Research suggests leucovorin may improve verbal communication in some children, although health leaders say that it is not a cure for autism<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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TUESDAY, Sept. 23, 2025 (HealthDay News) \u2014 A decades-old cancer drug may soon be approved to help kids with certain autism-related symptoms linked to folate deficiency.<\/p>\n
The U.S. Food and Drug Administration (FDA) is preparing to clear leucovorin<\/a> \u2014 a generic drug also known as folinic acid \u2014 for use in kids with cerebral folate deficiency and symptoms of autism.<\/p>\n The move, expected in the coming weeks, would mark a new use for the drug, which is already prescribed for patients with cancer and some forms of anemia.<\/p>\n Research suggests leucovorin may improve verbal communication in some children, although health leaders say that it is not a cure for autism.<\/p>\n “In the coming weeks, the FDA will approve prescription leucovorin as a treatment for children with cerebral folate deficiency and autistic symptoms,” FDA Commissioner Dr. Marty Makary<\/a>, National Institutes of Health Director Dr. Jay Bhattacharya<\/a> and Centers for Medicare & Medicaid Services head Dr. Mehmet Oz<\/a> wrote in an opinion piece<\/a>.<\/p>\n Once the FDA label change is made, Medicaid and the Children\u2019s Health Insurance Program (CHIP) will be required to cover the drug nationwide, they added.<\/p>\n More than half of all U.S. children are insured through those programs.<\/p>\n Some scientists say leucovorin shows promise for children who are folate-deficient, but they warn that the data is limited.<\/p>\n “It is important to note that leucovorin is not a cure for autism but has demonstrated an improvement in speech-related deficits for autism,” Makary, Bhattacharya and Oz added in their commentary.<\/p>\n In the same piece, they also advised pregnant women to use Tylenol (acetaminophen<\/a>) carefully and in consultation with their doctors. Some studies suggest a possible link between acetaminophen use during pregnancy and conditions like autism and ADHD<\/a> in children.<\/p>\n \u201cThese studies are looking for associations, they don\u2019t show causation,\u201d Dr. Peter Bernstein<\/a>, an obstetrician-gynecologist at Mount Sinai Hospital in New York City told Politico<\/em>. \u201cNot treating a fever may increase the risk of the pregnancy, certainly more than the Tylenol use.\u201d<\/p>\n On Monday, health regulators in the U.K. also reaffirmed acetaminophen\u2019s safety, saying there is no evidence it causes autism. Overseas, acetaminophen is called paracetamol.<\/p>\n \u201cPatient safety is our top priority. There is no evidence that taking paracetamol during pregnancy causes autism in children,\u201d said Alison Cave<\/a>, chief safety officer of the U.K.\u2019s Medicines and Healthcare products Regulatory Agency (MHRA). \u201cParacetamol remains the recommended pain relief option for pregnant women when used as directed.\u201d<\/p>\n More information<\/strong><\/p>\n The Mayo Clinic has more on leucovorin<\/a>.<\/p>\n