By JENNIFER SINCO KELLEHER
HONOLULU — The Hawaii Department of Health and federal agencies are warning the public to stop using a diet supplement and have asked retailers to take the product off the shelves after reports of hepatitis and liver failure around the state.
The department, the U.S. Food and Drug Administration and the Centers of Disease Control on Tuesday advised consumers to stop using OxyELITE Pro. The state is asking retailers to stop selling the product, and the manufacturer — USPlabs LLC, of Dallas — has informed the FDA that it will voluntary stop distributing OxyELITE Pro while the company cooperates with the investigation, according to the FDA.
The product is used for weight loss or muscle-building.
The FDA said it is also investigating whether counterfeits of the product were related to the cases of acute hepatitis after USPlabs informed the agency it believed counterfeit versions of OxyELITE Pro were being sold. The company said in a statement that “the cluster of liver issues in Hawaii is a complete mystery” and that all the company’s products are safe.
Hawaii health officials said 24 out of 29 cases under investigation reported using the supplement. All cases of acute hepatitis and liver failure occurred in all counties across the state from May through October.
The median age of the 29 patients is 33 and 14 are male, according to the CDC. Two required transplants. Eleven were hospitalized and two remain hospitalized.
“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,” states a CDC health advisory. “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.”
Hawaii News Now reported that Sonette Marras died last week after taking OxyELITE Pro to lose weight. The investigation began Sept. 25, said Health Director Loretta Fuddy. “We feel it is time to take more formal action,” she said.
State Deputy Director of Environmental Health Gary Gill said at least one store contacted Tuesday — a GNC at Ala Moana Center — said the store won’t remove the product. A store manager said he’s unable to comment.
Hawaii health officials are hoping retailers “do the right thing,” said Mark Berthold, public information officer for the department’s Disease Outbreak Control Division. “If there’s a situation that changes, there might be other sanctions down the road.”