US President Donald Trump held a press conference to announce the connection between the use of Tylenol, a popular pain and fever relief medicine during pregnancy and autism. Trump in the press conference also suggested Leucovorin, as a potential treatment for autism symptom.Read: Tylenol And Autism: Trump Announces Link Between The Two, Science Does Not Back Him What Is Leucovorin?It is known as folinic acid, a form of folate, also an essential B vitamin or B9, which has been approved by the US Food and Drug Administration (FDA) for counteracting the toxic effects of certain cancer drugs. It can counteract methotrexate that blocks body's use of folate. The drug is also used to enhance the effects of chemotherapy drugs and to treat specific types of anemia. How Is Leucovorin Administered? Who Makes Leucovorin?The drug can be administered orally or intravenously. While it is manufactured by dozens of companies, notes US FDA, on Monday itself, FDA published a notice to the Federal Register ahead of Trump's press conference to approve a version of Leucovorin manufactured by GlaxoSmithKline or GSK. GSK had previously withdrawn from FDA's consideration when it stopped making the drug. However, as per the FDA notice, "The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD (cerebral folate deficiency)."Is Leucovorin Effective For Autism?As per the FDA notice, leucovorin calcium, branded as Wellcovorin by GSK is sent for approval for patients with cerebral folate deficiency, which is a neurological condition that affects folate, an essential vitamin for brain health, transport into the brain.The FDA notice mentions that individuals with CFD have been "observed to have developmental delays with autistic features". FDA Commissioner Marty Makary, MF, MPH said that in over two decades, the US has "witnessed a tragic four-fold increase in autism". He further noted: "Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.” George Tidmarsh, MD, PhD, Director of the FDA's Center for Drug Evaluation and Research said that FDA is collaborating with GSK to broaden the existing Wellcovorin label and is committed to "finding and treating the root causes of autism".Read: Trump's Claim On Linking Tylenol And Autism Is Unscientific, According To Doctors Why Leucovorin Is Considered To Treat Autism?Doctors have been using leucovorin off-label for autism, repurposing the drug beyond its original approval, reported Reuters. Research from SUNY Downstate Medical Center and others suggests that as many as three-quarters of children with autism may have genetic variations or autoimmune issues that interfere with folate processing in the brain.Smaller studies have linked these problems to more severe autism symptoms and found that leucovorin treatment may help improve speech, social interaction, and irritability. Still, the Autism Science Foundation cautions that the research is in its early stages, and more evidence is needed before firm conclusions can be drawn.Read: Trump Suggests Changes In Childhood Vaccines, Says It Is Based On What He FeelsA 2016 study published in Molecular Psychiatry, which was a randomized controlled trial suggested that this specialized form of folate can improve communication and language skills in some children with Autism Spectrum Disorder (ASD). A June 2020 study published in the Seminars in Pediatric Neurology suggests folate (vitamin B9) plays a vital role in brain development and function, helping with DNA synthesis, methylation, and neurotransmitter production. Some children with autism struggle with folate metabolism, particularly in transporting folate into the brain, a condition known as cerebral folate deficiency.Another 2020 study published in October in Seminars in Pediatric Neurology suggests that in many cases, the immune system produces antibodies that target the folate receptor alpha (FRα) on brain cells. These folate receptor autoantibodies (FRAA) block folate entry into the brain, resulting in low brain folate levels even when blood levels are normal. While only about 5–10% of the general population carries these antibodies, research suggests that 50–70% of children with autism may have them. This disruption is thought to significantly affect speech and cognitive development.However, Dr. David Mandell, a professor of psychiatry and autism expert at the University of Pennsylvania, told Reuters that leucovorin might well be a possible treatment for some children with autism, "but the evidence we have supporting it... is really, really weak."
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