FDA: USPlabs OxyElite Pro Linked to Hepatitis, Liver Injuries

WASHINGTONUSPlabs LLC has agreed to stop distributing its energy and-fat burning supplement OxyElite Pro after Hawaii officials have linked it to 24 cases of acute non-viral hepatitis, FDA announced Tuesday.

Of the 29 cases of hepatitis and liver failure that are under investigation, FDA has reported 11 hospitalizations, two liver transplants and one death.

The agency advised consumers to stop using OxyElite Pro during its investigation.  

Maui resident Jeanette Kaipo told the Honolulu Star-Advertiser that her 48-year-old sister Sonnette Marras died last week after taking OxyElite Pro for several weeks to lose weight that she gained during her last pregnancy.

"Twenty-four cases reported using OxyElite Pro before their illness," said Sarah Park, state epidemiologist, in a news release from the Hawaii State Department of Health (DOH). "No other supplement or medication has been identified in common among more than two patients."

The patients who suffered illnesses have a median age of 33, and loss of appetite, dark urine, jaundice and light-colored stools are the most commonly reported symptoms, according to the Centers for Disease Control and Prevention (CDC) in a health alert. Two patients are still in the hospital, the health agency said.

CDC is investigating whether other cases of liver injury are related.

"National case finding efforts have identified several individuals from states outside Hawaii with reported OxyELITE Pro or other weight loss or muscle-building dietary supplement use prior to the development of acute hepatitis of unknown cause," the health agency stated. "CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these individuals to determine if this outbreak is national in scope."

The reported illnesses and epidemiological probe represent another setback for USPlabs, whose products containing a stimulant known as DMAA have been linked to more than 100 illnesses including six deaths.

In the most recent debacle, USPlabs believes counterfeit versions of OxyElite Pro are being marketed in the United States. FDA said it is looking into whether such counterfeit products are linked to the reported illnesses. FDA also is analyzing medical records and patients' histories as well as inspecting the facilities that made OxyElite Pro.

Dallas-based USPlabs has told the press it stands by its product, which is distributed online and at retail stores.  

"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," the company said in a statement released to the Honolulu Star-Advertiser. "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."

Earlier this year, USPlabs announced plans to reformulate products containing DMAA, otherwise known as dimethylamylamine.

FDA later seized supplements that contained DMAA at GNC and USPlabs facilities, including Jack3d and OxyElite Pro. FDA has warned consumers that DMAA could heighten blood pressure and lead to such cardiovascular problems as shortness of breath, tightening of the chest and a heart attack.

USPlabs ultimately agreed to destroy the supplements, which had a retail value of approximately USD $8.5 million, an FDA official wrote in a July 30 blog.