The Irish Health Chiefs (similar to the Surgeon General in the United States) just issued an alert over OxyElite Pro and Versa supplements, which are advertised for weight loss, muscle building, and energy boosting. The products have been blamed on liver injuries reported in the United States.
The Health Chiefs announced that the OxyElite Pro products and Versa-1 are to be pulled from store shelves; medical help should be sought by people who have taken the supplement, the Independent.ie reported. The Irish Medicines Board (IMB) and the Food Safety Authority Ireland (FSAI) said the involved products are OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, OxyElite Pro Super Thermo powder, and Versa-1.
John Lynch, IMB Director of Compliance stated that, in the past, some of these supplements have contained a substance that has deemed them to be illegal medicines. “People are advised that, if they are feeling any ill effects after taking any of these products, they should contact their doctor and, if possible, present the product in question,” Lynch told Independent.ie.
The OxyElite and Versa-1 products have been associated with severe liver injuries, including hepatitis and liver failure. In Ireland, one such case has been reported, according to Independent.ie. In the U.S. a larger number of cases are being seen, including one in which a patient died and others involving liver transplants and pending liver transplants.
The FSAI Director of Consumer Protection, Ray Ellard, said that online sellers have been advised to stop selling the supplement products, which contain aegeline. “Outlets such as gyms, sports supplement retailers and businesses selling supplements from websites are being asked to remove these products from sale and to clearly display a point-of-sale notice if they sold the products in the past,” Ellard told Indpendent.ie. “People are taking a serious risk by taking these products. We know that OxyElite Pro has, in the past, contained another unsafe ingredient and is now linked as a possible cause of acute hepatitis…. Consumers should not purchase these types of products online as there is no guarantee of their safety or what they actually contain,” Ellard added.
The U.S. Food and Drug Administration (FDA) announced that the maker of OxyElite Pro, USPlabs LLC of Dallas, Texas, is recalling some OxyElite Pro dietary supplements following an FDA letter stating OxyElite Pro products were associated with liver illnesses and there was a reasonable likelihood that the supplements are adulterated. The FDA also wrote that if USPlabs did not implement a voluntary recall, the agency could mandate the supplement maker cease distributing the product and could also advise other parties to stop distributing the supplements, as well.
The November 6th FDA letter also outlined findings involving an association between use of the recalled OxyElite Pro supplements and liver illnesses reported in Hawaii, and that other liver damage cases had been reported following ingestion of the recalled OxyElite Pro products in other states. A review of 46 medical records submitted to the FDA by the Hawaii Department of Health revealed that 27 patients (58 percent) had taken a dietary supplement labeled as OxyElite Pro prior to becoming sick. Of these, 27 patients (63 percent) reported that OxyElite Pro was the only dietary supplement they had taken.