Health officials are advising consumers to stop using a dietary supplement product labeled as OxyElite Pro because of a cluster of hepatitis cases in Hawaii among people who used the weight-loss supplement. They are also investigating whether it is linked to other cases nationwide.
Hawaii’s Department of Health is investigating 29 cases of hepatitis that have led to two liver transplants and one death. Eleven patients were hospitalized.
The first case was reported May 10 and the most recent Oct. 3, the Centers for Disease Control and Prevention said in the alert send to health-care providers on Tuesday. More than 80% of the patients reported using OxyElite Pro during the 60 days before they became ill.
“We’re calling for stores to voluntary remove this product from their shelves,” said Janice Okubo, a public information officer with Hawaii’s state health department.
The CDC alert told public health agencies, emergency departments and health-care providers to be on the lookout for patients who develop acute hepatitis or liver failure following use of a weight-loss or muscle-building nutritional supplement.
Several individuals from states outside Hawaii have been identified with acute hepatitis after taking OxyElite Pro or other weight-loss or muscle-building dietary supplements, the alert said. CDC is working with state health departments to collect more information about the cases.
The Food and Drug Administration is collecting samples of the product in Hawaii and testing them, Okubo said. FDA is also inspecting the facilities where the product was manufactured.
Neither FDA nor CDC could be reached for comment because of the government shutdown.
OxyElite Pro is a dietary supplement sold as a weight-loss aid. It is distributed by USPlabs LLC of Dallas and sold nationwide. The company told FDA it believes counterfeit versions of OxyElite Pro are being marketed in the United States, FDA said in a release Tuesday.
In a statement e-mailed Tuesday, the company said the cluster of liver issues “is a complete mystery and nothing like this has ever been associated with OxyElite Pro.”
Out of “an abundance of caution” the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed, the company said.
The symptoms of hepatitis can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes and jaundice.
Hepatitis is an inflammation of the liver. It can be caused by either viral diseases or medications that can damage the liver.
Health officials tested all the patients for the viral forms of hepatitis and none of them had it, said Pieter Cohen, an expert on dietary supplements with the Cambridge Health Alliance in Cambridge, Mass.
With viral hepatitis ruled out, “physicians must look carefully at medications and herbal ingredients that might be linked to the liver failure,” Cohen said. Some ingredients, in rare instances, can cause liver failure.
How such ingredients might have made their way into the supplement isn’t known. One possibility is that the label was not accurate.
“Unfortunately, we see that not infrequently with supplements. There’s one thing on the label and something else in the pills,” Cohen said.
Consumers should know that there is no such thing as a fat-burning pill, Cohen said. “The idea that there is a natural weight-loss pill out there is hogwash. Either the pills don’t work or they do work because they contain substances which are not natural and are pharmaceuticals,” he said.
