HONOLULU—A 2013 hepatitis outbreak that was linked to a fat-burning supplement manufactured by USPlabs LLC may have affected nearly 100 people in more than a dozen states.
The Centers for Disease Control and Prevention (CDC) reported 97 cases and one death in 16 states including Hawaii that met its case definition, said Bernadette Burden, a CDC spokesperson. The figure is up from 56 cases reported in early November 2013.
CDC does not explicitly reference consumption of OxyElite Pro in its definition of a "case." The health agency previously defined a case "as acute hepatitis of unknown etiology occurring on or after April 1, 2013, in a person who had consumed a weight-loss or muscle-building dietary supplement within the previous 60 days" and met certain other requirements.
Dallas-based USPlabs did not respond to a request for comment on the current number of cases under investigation.
Roughly half the cases are in Hawaii, where local officials last year reported one death and the need for two liver transplants.
David Johnston, ELC epidemiologist with the Hawaii Department of Health's Disease Outbreak Control Division, said the agency continues to investigate the outbreak. Forty four individuals have reported using OxyElite Pro and met the agency's definition, he said. Of those individuals, 15 were hospitalized, Johnston said.
USPlabs last year defended the safety of an ingredient (aegeline) in OxyElite Pro in a letter to FDA, citing tests and clinical data on the substance. Still, the company agreed to reformulate the supplement by removing aegeline, which FDA declared was not proven to be safe, and destroy the remaining inventory of aegeline-containing OxyElite Pro. FDA indicated last year that the destroyed supplements were worth USD $22 million.
USPlabs expressed the belief that counterfeit versions of its OxyElite Pro were marketed in the United States. Arthur Whitmore, an FDA spokesperson, said the agency has not confirmed any products were counterfeit.
FDA and Hawaii officials previously noted victims of the outbreak were not predisposed to liver disease, increasing the likelihood that OxyElilte Pro was responsible for the illnesses. The CDC also excluded certain individuals from its case definition including those people who suffered chronic alcohol use, preexisting autoimmune hepatitis, and chronic liver diseases, such as hemochromatosis and Wilson's disease.
Thanks in part to the outbreak, USPlabs is facing a number of lawsuits over its sports supplements and has moved to consolidate the complaints before one federal court.