At various Monday press conferences Autism topicsfederal health officials pointed out that existing cancer drugs could double as treatments for neurodevelopmental conditions.
FDA Commissioner Marty McCurry, Director of National Institutes of Health (NIH) Jaybatacharia, Medicare and Medicaid Services Administrator, Centers at Mehmet Oz, Leucoborin, Prescription vitamins It is used to treat cancer and anemia and is effective for off-label use in children with autism.
According to a press release from HHS, the FDA plans to approve the prescription leucovorin as “a potential treatment for voice-related deficits associated with ASD.” The agency will update the label for leucovorin to indicate treatment for brain folate deficiency associated with autism.
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After the label update, the state Medicaid program will be able to cover drugs for autism treatment, the release says.
The NIH will also launch a new research initiative on the safety and efficacy of Leucovorin.
Research shows that leucovorin can help some Nonverbal children Gain the ability to speak.
Leucovorin works similarly to folic acid and helps in recovery Folic acid levels According to Katy Dubinsky, a New York pharmacist and CEO and co-founder of Vitalize, a private supplement company, the patient is a difficult patient to absorb or use.
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“Leucovorin is FDA approved to reduce the toxic effects of high-dose methotrexate in cancer treatments and to prevent or treat certain types of anemia caused by folate deficiency,” Dubinsky told Fox News Digital.
meanwhile Leucovorin has not been prescribed yet For treatment of autism, some families have found that its off-label use has led to significant improvements in communication skills in children with autism, experts say.
Richard E. Fry, MD, PhD, Behavioral Child Neurologist in Arizona, studied drugs in a study of experimental treatments for children with autism spectrum disorder.
“Leucovorin is a special form of vitamin B9 that is water soluble and does not accumulate in your body,” he previously told Fox News Digital.
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“For many years, folic acid has been replenished with food because folic acid has been known to be safe in the long term.”
The main benefit of leucovorin for children with autism is improved language, Fry said, but other benefits may include enhanced social functioning, reduced repeat behavior, and strong Caution Skills.
“We found that leucovorin helps a considerable number of children with autism,” he said. “Language is one of the most obvious, so it was measured in clinical trials.”
Dr. Mark Siegel, The professor of clinical medicine, a senior medical analyst at NYU Langone Health and Fox News, also spoke to Fox News Digital about why the drug has a positive effect.
“Central Folic Acid Deficiency is a lack of folic acid in the brain and can interfere with it Neurological functions“He said earlier this year.
Leucovorin is converted to folic acid in the brain by different pathways, Siegel said.
“Small studies show that it will improve Neurological functions Communication skills in children with ASD need to be conducted with greater research. ”
The fact that leucovorin is already in long term use helps reduce the associated risks, doctors say.
“One of the benefits of using leucovorin is that it has been used for decades to protect the body. The effects of chemotherapyso we know the doses we use and the side effects it may produce,” Fly told Fox News Digital.
However, some children become “very hyperactive,” and do not respond to leucovorin and need alternative treatments, doctors noted.
It is important for families to work together Medical professionals He advised when exploring the use of leucovorin for autism.
“Leucovorin is administered at a much higher dose than a regular vitamin, so it’s very important to work with a doctor who is knowledgeable about how to prescribe it,” Frye said.
Leucovorin is available at pharmacies, but Fry said that some children need a complex form as they are sensitive to some additives in over-the-counter products.
“Our goal is to approve leucovorin by the FDA for autism. Prescribed to children He said before.
Dubinsky agreed that doctors would prescribe “widely used and well-tolerated drugs” to treat autism based on “clinical judgments and new evidence,” but also highlighted the importance of clinical trials.
“FDA approval provides stronger medical assistance and is a recognized treatment rather than just an off-label option,” she told Fox News Digital.
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“This could lead to insurance coverage, standardized administration guidelines and wider acceptance. Medical world. ”
Siegel added that leucovorin is a “safe drug” and that large-scale use should be considered based on the results of recent research.
Frye says autism “no magic bullets” and many children benefit from multiple treatment combinations.
“It is unlikely that leucovorin will be used alone, and it should be used in behavioral and speech therapy,” he said. “We believe that leukoborin can be done. Improve the results For these treatments. ”
Dr. Andy Shee, Chief Science Officer of Autism, is the Chief Science Officer of New York, noted that the experiences of every child with autism are unique.
“There is little evidence to suggest any observed benefits. [in individual cases] It can generalize to the wider autism community,” he previously told Fox News Digital.
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“Some small studies have explored leucovorin as a potential treatment for people with autism, but with greater controls Clinical trials It is necessary to determine its effectiveness and safety. We encourage family members to consult with their doctor before considering off-label treatment. ”
Dubinsky added that if a large study confirms the effectiveness of leucovorin, it could become a more accessible treatment for children with autism who might benefit from it.
