FDA Links Weight-Loss Drug OxyElite Pro to Hepatitis and Liver Failure Cases in Hawaii
The FDA has announced that the popular weight-loss drug, OxyElite Pro, has been linked to cases of hepatitis, and subsequent liver failure, that showed up in Hawaii recently.
So far, about 29 people have been diagnosed with acute hepatitis in Hawaii. One patient has died, and two patients had to undergo liver transplants. Eleven patients have been hospitalized.
According to FDA investigations, more than 80% of those people were consumers of weight-loss supplement OxyElite Pro. Their reports determined that the hepatitis patients consumed the drug for about 60 days before displaying symptoms of the liver-damaging illness.
“The cluster of liver issues is a complete mystery and nothing like this has ever been associated with OxyElite Pro,” USPLabs LLC, the manufacturer, mentioned in a statement in an e-mail this Tuesday.
The FDA is currently investigating if OxyElite Pro can be linked to other instances of hepatitis nationwide. So far, their investigations have been limited to Hawaii.
“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 has issued an alert to public health agencies, emergency departments, and health-care providers to look out for patients who develop acute hepatitis or liver failure in conjunction with taking OxyElite Pro. Meanwhile, the FDA is collecting samples of the drug in Hawaii and testing them, as well as inspecting the facilities where OxyElite Pro is manufactured.
OxyElite Pro is manufactured by USPLabs LLC of Dallas, Texas, and sold nationwide. The company added in their Tuesday, October 8th statement, that they believe counterfeit versions of the drug could be on the market in the US. However, the company has decided to cease manufacturing OxyElite Pro, along with OxyElite Pro Super Thermo Powder, until the investigation is completed.
Hepatitis patients in Hawaii have been tested for the viral form of the disease, and none of them have it. Instead, what they have is probably medication-related inflammation of the liver, which can cause symptoms similar to that of the viral form of the disease.
Hepatitis symptoms can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellowed eyes and skin, and jaundice.
Dietary supplements in the US are not regulated as heavily as medication, so many supplements could have herbal or active ingredients not listed on the label.
“Unfortunately, we see that not infrequently with supplements. There’s one thing on the label and something else in the pills,” said Pieter Cohen, an expert on dietary supplements with the Cambridge Health Alliance in Cambridge, Mass.
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