HONOLULU (AP) -- 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, including one death.
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.
In 2012, FDA warned companies with products containing a geranium extract known as DMAA that they needed to be taken off the market or reformulated to remove the substance. USPlabs received a warning letter because two of its products contained DMAA, FDA spokesman Steven Immergut said.
The FDA will evaluate whether the OxyELITE Pro product used by many of the Hawaii patients was the old formulation containing DMAA or the newer, reformulated product, Immergut said.
The company said the original version with DMAA hasn't been manufactured or distributed since early 2013 and that it has stopped domestic distribution of the reformulated pill and powder versions that are available.
Hawaii health officials said 24 out of 29 cases under investigation reported using OxyELITE Pro. All cases of acute hepatitis and liver failure occurred in every county in 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."
Sonnette Marras died last week after taking OxyELITE Pro for several weeks to lose weight gained during her last pregnancy, said her sister, Jeanette Kaipo. Marras, 48, of Maui, had seven children, ranging in age from 1 to 26, Kaipo said.
The investigation began Sept. 25, Health Director Loretta Fuddy said.
State Deputy Director of Environmental Health Gary Gill said at least one store contacted Tuesday — a GNC at Ala Moana Center — said it 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."
