FDA probes liver damage cases potentially linked to “fat burning” supplement
Reflecting on the link between USPlab’s OxyELITE Pro, a dietary supplement, and the subsequent development of liver damage and other potentially life-threatening side effects, the U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using the products.
29 cases under investigation
The agency is probing at least 29 cases of acute hepatitis, liver failure, and liver transplants that have occurred in Hawaii from May through October possibly related to the use of OxyElite Pro, billed by its makers USPLabs LLC as a “fat burner” and an “appetite suppressor.” According to the health regulators 11 patients were hospitalized with acute hepatitis, two received liver transplants and one died.
“Twenty-four cases reported using OxyElite Pro before their illness,” said Dr. Sarah Park, State Epidemiologist. “No other supplement or medication has been identified in common among more than two patients.”
FDA looking at other cases of liver injury
Although Hawaii has witnessed the largest and most recent cluster of cases, the national health experts and the FDA are looking at other cases of liver injury elsewhere in the nation to see if they are related. OxyElite Pro is sold throughout the United States via the Internet and retail stores.
The FDA health advisory states, “Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, the FDA is also investigating whether a counterfeit product is related to any of the cases of acute hepatitis.”
Voluntary recall issued
The Hawaii Department of Health has requested the “voluntary removal” of OxyELITE Pro from Hawaii retailers, and urged consumers to discontinue use of the diet supplement in order to avoid any undue risk.
Though USPLabs don’t believe their products are responsible for the liver illnesses in Hawaii, the company is offering total support and co-operation to the FDA and has stopped distributing two of its supplements while the investigation is underway.
In its written statement today, USPlabs said the company said, “The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues.”