The Food and Drug Administration on Monday announced that it’s in the process of approving a tablet version of Leucovorin, a form of folate (Vitamin B9), also known as folinic acid, to treat speech-related difficulties in children with autism who are folate-deficient. Often administered to cancer patients alongside chemotherapy in the form of an IV, Leucovorin, is now being explored as a potential treatment to improve autism symptoms.
Leucovorin is used to relieve side effects linked with some chemotherapy drugs and to treat some types of anaemia resulting from folic acid deficiency, according to National Institutes of Health (NIH). It can also enhance effects of chemotherapy drug 5-fluorouracil.
However, Leucovorin has now got FDA nod for treating cerebral folate deficiency, a neurological condition, that can lead to low levels of vitamin B9 (folate) levels in the brain. Folate aids in red blood cell production and cell growth. It also helps reduce the risk of birth defects in a baby’s brain or spine, according to Mayo Clinic.
Leucovorin for autism treatment
Some clinical trials show that leucovorin can significantly improve speech and social communication skills in some children with ASD, particularly those with folate pathway abnormalities or folate receptor autoantibodies (FRAAs).
Researchers, however, feel the FDA approval could be premature due to insufficient clinical trials.
Alycia Halladay, chief science officer at the Autism Science Foundation told NBC News that Leucovorin “doesn’t have the criteria to meet FDA approval.
In a new release, FDA has said the drug is being approved for patients with cerebral folate deficiency. However, not all autism patients may have the condition.
How Leucovorin may help autism patients
Leucovorin aids in folate’s passage to brain, which may improve verbal communication or reduce symptoms like irritability or repetitive behaviour in autism patients, according to a Molecular Psychiatry study. But there is no scientific evidence that it eliminates autism symptoms completely.
A review published in Journal of Personalized Medicine found that children who took the drug experienced improved autism symptoms. However, the authors said more studies were needed to confirm the findings.
Another study published in the European Journal of Pediatrics examined the effect of folinic acid in Chinese children with autism who experienced greater improvement in social skills compared to children on placebo.
Side effects of leucovorin
Leucovorin has its own sets of side effects including severe allergic reactions, seizures and fits, and nausea and vomiting, according to National Institutes of Health.
What is Autism spectrum disorder?
Autism spectrum disorder (ASD), a condition affecting brain development, causes problems in communication and forming social connections. Associated with limited and repeated patterns of behavior, the spectrum includes autism, Asperger’s syndrome, childhood disintegrative disorder and a form of widespread developmental disorder.
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