USPlabs of Dallas has recalled OxyElite Pro dietary supplements after the Food and Drug Administration stated the products have been linked to liver illnesses and hepatitis. The pills are used for weight loss and muscle-building.
In October, 2013, a 48-year-old woman in Hawaii who took the pills died of liver failure. Her family said she took the pills for only weeks before becoming violently ill. Dozens of other cases of liver failure and acute hepatitis have been reported in Hawaii over the last six months. Cases of liver damage that may be linked to the supplement are now being reported elsewhere.
The FDA has said people in at least 12 other states have been connected to the outbreak since the end of October. For example, a 45-year old San Diego woman reportedly suffered acute liver failure after using Oxy Elite Pro for weight loss. Similarly, a 33 year-old Cleveland woman was recently hospitalized due to liver damage after taking the supplement.
USPlabs is voluntarily conducting a national recall of all lots and sizes of its OxyElite Pro dietary supplement products. The products contain aegeline, a synthesized version of a natural extract from the Bael tree. The FDA says aegeline is “a new dietary ingredient”—an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling.
According to the FDA, epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure. Investigations are ongoing into a potential causal relationship. The product was distributed nationwide through retail stores, mail orders and direct delivery. A list of the specific products is available at the FDA website.
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