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FDA Probing Whether Bodybuilding Supplement OxyElite Pro Causes Liver Illnesses

Filed October 28th, 2013 Laurie

Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) called on public health agencies, emergency departments, and healthcare providers to be on the lookout for patients who develop acute hepatitis and liver failure after using the bodybuilding supplement OxyElite Pro.

The FDA’s investigation is ongoing and it is advising consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 because they contain an ingredient known as aegeline, for which USP Labs, the supplements’ manufacturer, has not provided adequate evidence of safety.

The FDA sent the manufacturer a warning letter on October 11 informing the company that failure to immediately cease distribution of the adulterated products would result in enforcement action by the agency.

The warning letter suggested that there may be a link between OxyElite Pro and several liver illnesses reported in Hawaii. reported that, as of October 14, 45 cases of liver illnesses had been reported to the Hawaii Department of Health (DOH). Twenty-nine of those patients were confirmed to have acute hepatitis after using a nutritional supplement for weight loss and muscle building.

The FDA is inspecting the facilities involved in the manufacturing of OxyElite Pro and VERSA-1, reviewing production and product distribution records. The agency also is looking into whether counterfeit products are responsible, since USP Labs has informed the agency that it believes counterfeit products have been marketed in the U.S. for some time.

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