US: FDA approves leucovorin drug in autism treatment

According to a VNA reporter in Washington, President Donald Trump announced on September 22 that the US Food and Drug Administration (FDA) has approved leucovorin (folinic acid) - a form of folic acid used to prevent and treat poisoning caused by folic acid antagonists, as a treatment to reduce autism symptoms.

Leucovorin was once manufactured and sold by GlaxoSmithKline under the trade name Wellcovorin, but was later withdrawn from the market for reasons of safety or effectiveness.

Leucovorin has long been FDA-approved to reduce side effects of certain chemotherapy drugs and is sometimes used off-label to treat vitamin B9 deficiency.

Leucovorin is a form of folate - an essential vitamin that helps cells grow, supports immunity and makes healthy red blood cells. Folate deficiency during pregnancy has been shown to cause neural tube defects.

Some studies have also suggested a link between low maternal folate levels in early pregnancy and autism risk in children, although results have been inconsistent.

Over the past 10 years, some physicians have prescribed leucovorin “off-label” for children with autism.

Small studies suggest that up to three-quarters of children with autism have a gene variant that affects folate processing or an immune disorder that prevents folate from entering the brain.

Several limited-scale trials indicate that leucovorin may improve language ability, social skills, and reduce irritability in these children.

Still, the scientific community remains cautious. The Autism Science Foundation notes that current data are based on just four small randomized trials, with inconsistent doses and results, and some studies only applied to a specific gene variant.

Professor David Mandell, a psychiatrist and autism expert at the University of Pennsylvania, stressed: “Leucovorin may be helpful for some children, but the current evidence is very weak.”

In addition, President Trump also said the administration is issuing a warning to doctors not to recommend acetaminophen - the active ingredient in Tylenol and many other popular drugs - to pregnant women, arguing that acetaminophen may be linked to autism in children.

President Trump stressed that “taking Tylenol is not good." Most scientific studies have not determined a link between acetaminophen and autism.

Acetaminophen was first introduced in the United States in the 1950s as a prescription alternative to aspirin. By the 1970s, it was available over-the-counter and had become one of the most widely used pain relievers and fever reducers in the United States.

According to a 2014 study published in the journal American Family Physician, between 40 and 65 percent of women use acetaminophen at some point during pregnancy.

President Trump made the announcement as Health and Human Services Secretary Robert F. Kennedy Jr. and other health officials pledged to identify the cause of the developmental disorder by September.

National Institutes of Health (NIH) Director Jay Bhattacharya said the agency will dedicate $50 million to 13 research projects focused on identifying root causes and treatments for autism, an effort called the “autism data science initiative.”

Research will focus on environmental and medical factors, nutrition, events during pregnancy, biology and genetics./.

(TTXVN/Vietnam+)

Source: https://www.vietnamplus.vn/my-fda-phe-duyet-thuoc-leucovorin-trong-dieu-tri-tu-ky-post1063425.vnp