The U.S. Food and Drug Administration (FDA) has announced that USPLabs LLC is recalling certain of its OxyElite Pro dietary supplements after reports linking the products to liver illnesses.
The Hawaii Department of Health submitted 46 medical records to the FDA for review. These records indicated that 27 people had become ill after taking a product labeled as OxyElite Pro. Of these individuals, 17 reported that they were taking no other supplements in addition to OxyElite Pro. One death has been reported among these individuals, one person has needed a liver transplant, and others are awaiting liver transplants.
On November 6, 2013, the FDA notified USPLabs regarding the association between OxyElite dietary supplements and the development of liver illnesses in Hawaii. The FDA reported that cases of liver damage have also been found in other states.
In the warning letter, the FDA informed USPLabs that OxyElite Pro and another product called VERSA-1 were found to contain a substance known as aegeline. This ingredient lacks a history of use as well as other safety evidence. The FDA stated in its letter that failure to stop product distribution of aegeline-containing supplements might result in enforcement action.
The FDA has warned consumers to avoid using any dietary supplements that are labeled as OxyElite Pro or VERSA-1.
Consumers who believe that they may be experiencing negative side effects associated with these products should contact a medical professional. Healthcare providers and consumers are advised to report side effects related to the use of these supplements to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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