FDA Suggests "Causal Connection" between OxyElite Pro, Liver Failure

WASHINGTONHealth findings "suggest a causal connection" between a dietary supplement known as OxyElite Pro and severe illnesses that have been reported in Hawaii, FDA warned the product's marketer USPlabs LLC last week.

The energy and fat-burning supplement has been linked to 24 cases of hepatitis and liver failure, including two liver transplants and one death. Health officials urged consumers to discontinue use of the product.

Although FDA is typically reticent to immediately blame a product for illnesses, the agency pointed to several factors that increase the likelihood that OxyElite Pro played a role in the cases of acute non-viral hepatitis.

In a review of 20 medical records submitted to the agency by the Hawaii Department of Health, the records indicated 70 percent of patients ingested OxyElite Pro before they fell ill, William Correll of the agency's Center for Food Safety and Applied Nutrition (CFSAN) wrote in the Oct. 11 letter to USPlabs president Jacob Geissler. Correll is Acting Director of CFSAN's Office of Compliance.

"There were no other consistent commonalities among the fourteen (14) patients other than exposure to Oxy Elite Pro," Correll stated. "Importantly, eight (8) patients reported Oxy Elite Pro as the sole dietary supplement they took prior to becoming ill, and most of these patients had been entirely healthy before they became ill."

He added most patients recovered after they stopped taking the supplement, "implying Oxy Elite Pro was the cause of the illness."

"And finally, rigorous clinical protocols were followed in the care of the patients to exclude and/or rule out known causes of liver disease (e.g., viral causes of hepatitis, autoimmune conditions, hemochromatosis, Wilsons disease, excess alcohol or acetaminophen ingestion and alpha-1-antityrpsin deficiency)," Correll wrote.

USPlabs agreed to stop distributing OxyElite Pro after Hawaii officials linked it to 24 cases of acute non-viral hepatitis. The patients who suffered illnesses have a median age of 33; the most common symptoms reported included the loss of appetite, dark urine, jaundice and light-colored stools, according to the Centers for Disease Control and Prevention (CDC) in a health alert. CDC is investigating whether other cases of liver injury are related.

FDA indicated a particular dietary ingredient known as aegeline could have played a role in the illnesses. 

"FDA is aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElitePro and Versa-1," Correll stated, warning USPLabs that the ingredient is "adulterated" because it does not meet requirements under federal law.

Dallas-based USPlabs has not responded to INSIDER's requests for comment on the outbreak. But the company has defended its product, which is distributed online and at retail stores. 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.

"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," USPlabs said in a statement released last week 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."