Unlabeled prescription drugs have been shown to help some nonverbal children with autism discover their ability to speak.
According to Katy Dubinsky, a New York pharmacist and CEO and co-founder of Vitalize, the drug, Leucovorin, is a formulated vitamin that works just like folic acid. , a private supplement company.
“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.
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Leucovorin is not prescribed for treatment of autism, but 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, Behavioral Child Neurologist in Arizona, studied the drug in a study of experimental treatments for children with autism spectrum disorder.
Unlabeled prescription drugs have been shown to help some nonverbal children with autism discover their ability to speak. (istock)
“Leucovorin is a special form of vitamin B9 that is water soluble and does not accumulate in your body,” he told Fox News Digital.
“For many years, folic acid has been replenished with food because folic acid has been known to be safe in the long term.”
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The main advantage of leucovorin for children with autism is improved language, Fry said, but other benefits include enhanced social functioning, reduced repetitive behavior, and stronger attentional skills. May be included.
“Our goal is to approve leucovorin by the FDA for autism, and it could be widely prescribed to children as one of the first treatments diagnosed.”
“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.
Although leucovorin is not prescribed for autism treatment, some families found that its off-label use has led to significant improvements in communication skills in children with autism. (istock)
“Central folate deficiency is a lack of folate in the brain, which can interfere with neurological function,” he said. “The high proportion of children with autism spectrum disorders has been shown to have antibodies to the lysate receptor alpha in the brain.”
Leucovorin is converted to folic acid in the brain by different pathways, Siegel said.
“Small studies have shown that neural function and communication skills are improved in children with ASD, but larger studies are needed.”
Experts caution
According to doctors, the fact that leucovorin is already in long term use helps reduce the associated risks.
“One of the benefits of using leucovorin is that it has been used for decades to protect the body from the effects of chemotherapy. So, the doses it uses and the side effects it may produce. I know that,” Frye told Fox News Digital.
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However, some children become “very hyperactive,” and do not respond to leucovorin and require alternative treatments, doctors noted.
He advised that it is important for families to work with medical professionals in exploring the use of leucovorin for autism.
The drug is a prescription vitamin that functions similarly to folic acid, which, according to pharmacists, can help restore folic acid levels in patients who have difficulty absorbing or using it. (istock)
“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.
“It is important to test patients for abnormalities in the folate pathway, such as folate receptor autoantibodies. That’s why we know we’re a candidate for this drug.”
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Leucovorin is available in pharmacies, but Fry noted that some children are sensitive to some of the additives in over-the-counter products and therefore require a composite form.
“Our goal is to approve leucovorin by the FDA for autism, which could potentially be widely prescribed to children as one of the first treatments diagnosed,” he said. I said that.
Frye points out that autism “has no magic bullets,” and many children benefit from multiple treatment combinations. (istock)
Dubinsky agreed that doctors would prescribe “widely used and well-tolerated drugs” for autism treatment based on “clinical judgments and new evidence,” but she said in clinical trials. He also emphasized the importance.
“Doctors can now prescribe leucovorin, but FDA approval provides stronger medical assistance and is a recognized treatment rather than just an option for the person indication,” she told Fox News Digital. I spoke.
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“This could lead to insurance coverage, standardized administration guidelines and wider acceptance within the medical community.”
Siegel added that leucovorin is a “safe drug” and that large-scale use should be considered based on the results of recent research.
“There’s no magic bullet”
Frye points out that autism “has 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 leucovorin can improve the outcomes of these treatments.”
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the wider autism community.”
Andy Shee, Chief Science Officer of Autism, is New York’s Chief Science Officer, noted that the experiences of every child with autism are unique.
“There is little evidence to suggest that the benefits observed in this individual case can be generalized to the wider autism community,” he told Fox News Digital.
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“Some small studies have explored leucovorin as a potential treatment for people with autism, but larger controlled clinical trials are needed to determine its efficacy and safety. We encourage families to consult with their doctor before considering extralabel 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.
