Food and Drug Administration Commissioner Dr. Martin A. Makary announced that the FDA is filing a federal register notice to change the label on Leucovorin, so it can be prescribed to treat children with autism.
Dr. Makary made the announcement Monday at the White House when President Trump, flanked by his leadership team at Health and Human Services, linked autism to the use of painkiller acetaminophen during pregnancy.
Leucovorin, also known as folinic acid, is an active metabolite of folic acid, or vitamin B9.
“You know, autism may also be due to an autoimmune reaction to a folate receptor on the brain not allowing that important vitamin to get into the brain cells,” Dr. Makary said.
“It’s a fairly established, mature pathway. Again, we have a duty to let doctors and the public know we’re going to change the label to make it available.”
“Hundreds of thousands of kids, in my opinion, will benefit,” he said. “One study found that with kids with autism and chronic folate deficiency, two-thirds of kids with autism symptoms had improvement, and some marked improvement.”
Dr. Makary, National Institutes for Health Director Dr. Jay Bhattacharya and Centers for Medicare and Medicaid Services Administrator Dr. Mehmet Oz talked about research that suggests leucovorin may help children who are deficient in folate.
The Trump administration is ramping up distribution and access of the treatment to patients.
“Over half of all American children are covered by Medicaid or CHIP, so upon this FDA label change, states will be required to cover leucovorin around the country,” Dr. Oz noted.
“States will also have tools to monitor its use and ensure appropriate utilization. That’s important for a bunch of reasons, because we want the right kids getting the right prescription medications. We believe private insurance companies will rapidly follow our lead, if they have not already done so.”
Dr. Oz added, “Again, to make sure that this is safe and effective treatment, you need a physician to prescribe the prescriptive medication, because it’s on prescription.”
• Kerry Picket can be reached at kpicket@washingtontimes.com.
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