Twenty-nine confirmed cases, 11 hospitalizations, two liver transplants and one death later, the state Department of Health on Tuesday finally confirmed the name of the dietary supplement linked to a surge in acute liver inflammation and liver failure in the isles, asking that sale of the product come to a halt.
Health Department staff traveled store to store Tuesday appealing to local retailers to voluntarily remove all formulas of the marketed "fat burner" OxyELITE Pro from their shelves while the agency continues to work with the Food and Drug Administration and Centers for Disease Control to investigate the precise cause of the rash of cases.
State health officials and the FDA also are advising the public to discontinue using the dietary supplement while the investigation continues.
Of the 29 cases of nonviral acute liver inflammation and/or failure in Hawaii from May to October linked to consuming a weight loss or a muscle-gaining supplement, OxyELITE Pro was the sole supplement being consumed in 24 of the cases, Health Director Loretta Fuddy said at a news conference Tuesday. Only one other supplement is being investigated, but Fuddy said she did not know the name of that product.
"We feel at this point in time that we have enough of an association between (OxyELITE Pro) and the cases that we are investigating that we feel it is time to take more formal action," Fuddy said.
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 in a story by The Associated Press.
Dallas-based USPlabs LLC, which manufactures the OxyELITE Pro product line, announced Tuesday that it had voluntarily stopped national distribution of two of its OxyELITE Pro formulas "out of an abundance of caution" because of the Hawaii investigation. The company said it stopped producing a third formula earlier this year after the FDA in April 2012 warned that one of its ingredients, DMAA (also known as 1,3-dimethylamylamine), was being used illegally.
But the company said it stands by its product and "continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii."
It is unknown which OxyELITE Pro formula those affected were taking, state Epidemiologist Sarah Park said Tuesday.
In the meantime the department is asking Hawaii retailers to discontinue sale of all formulas of OxyELITE Pro, said Gary Gill, deputy director of environmental health.
Stores known to be selling the product include, but are not limited to, 17 GNC locations and four Vitamin Shoppes on Oahu, as well as others on neighbor islands, Gill said.
The cases have been reported in each of the state’s four counties.
At least one GNC store, however, told the state Tuesday it would not comply with the voluntary request.
"Preliminarily we have one report so far that the GNC store in Ala Moana Center has told our inspector that they choose not to remove the product from the store," Gill said. "We will be following up with that over the next few days."
Greg Miller, a spokesman for GNC, said in an email statement sent to the Honolulu Star-Advertiser that the company "will continue to sell the OxyELITE product in its stores until such time that either USPlabs or the FDA recall the product."
The FDA in an advisory posted Tuesday said it is reviewing the medical records and histories of patients identified by Hawaii officials, analyzing the composition of product samples collected, inspecting the facilities involved in manufacturing the product, and reviewing production and product distribution records.
The agency said it is also looking into a claim by USPlabs "that it believes counterfeit versions of OxyELITE Pro are being marketed in the U.S. and have been on the U.S. market for some time."
Park, however, told the Star-Advertiser last week that everyone the department contacted appeared to have bought the product legitimately.
The CDC also posted an advisory on its website Tuesday informing consumers and physicians of the situation in Hawaii and asking that suspected cases be reported.
Fuddy said the CDC has had four workers in the isles assisting with the investigation since Sept. 27 and that the department, the FDA and the CDC hold meetings each morning regarding the investigation. She added that three cases have turned up in three other states so far, and she suspects more cases will turn up around the country now that the advisory has gone out because the same happened in Hawaii once the department sent out its notice.
The original formula of OxyELITE Pro that contained DMAA was banned in 2012 for use in dietary supplements after FDA had received 86 reports of illnesses or death since 2008, including heart problems and nervous system or psychiatric disorders.
The FDA issued a warning in 2012 that "one company that has yet to agree to such action, USPlabs, has responded to the FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions."
According to a blog post written by the director of the agency’s Division of Dietary Supplement Programs on July 30, the company’s response prompted Texas to temporarily put an embargo on the products. The FDA used its authority to keep it out of the marketplace for up to 30 days while the agency considered other legal steps such as seizure or injunction. Dr. Daniel Fabricant of the FDA wrote that USPlabs agreed to destroy the stock before the 30 days were up.
GNC was also at the center of that situation, as The New York Times reported in June that the company continued to sell its inventory of DMAA products even after USPlabs announced it would comply with the FDA’s request to stop making them.
In the FDA’s July post, Fabricant said the agency oversaw the destruction of OxyELITE Pro DMAA products at GNC facilities in Pennsylvania and Arizona, and that the company was expected to soon after destroy its remaining supply in South Carolina. He cautioned, however, that "some products with DMAA may remain available on the Internet or store shelves while we continue working on this problem."
Gill said the department will take the next step of embargoing the products if it believes that is necessary.
"We’re doing the appropriate action given the information that we have at this point," he said.
ALARMING LINK The OxyELITE Pro supplement, which users take for weight loss or building muscles, is suspected in a rash of cases of acute hepatitis and liver failure in Hawaii. It has been linked to 29 cases, including two liver transplants and one death since May, prompting state health officials to call on retailers to remove the product from store shelves.
NONVIRAL HEPATITIS Hepatitis is an inflammation of the liver. Nonviral hepatitis is classified as toxic- or drug-induced hepatitis. Most patients recover from this illness, although a few develop fulminating hepatitis or cirrhosis.
THE LIVER The largest internal organ removes toxic wastes, helps the body absorb nutrients and makes clotting factors.
SIGNS AND SYMPTOMS Clinical features of toxic- and drug-induced hepatitis vary with the severity of liver damage and the causative agent. In most patients, symptoms resemble those of viral hepatitis: >> Loss of appetite >> Nausea >> Vomiting >> Jaundice >> Dark urine >> Hepatomegaly >> Abdominal pain >> Clay-colored stools
TREATMENT Remove the harmful substance. Flush from the stomach or induce vomiting. Patients with drug-induced hepatitis may be prescribed corticosteroids.
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