Ireland's Health Chiefs Issue Alert Over OxyElite, Versa-1 SupplementsNov 14, 2013
An alert over OxyElite Pro and Versa supplements has been issued in Ireland by its Health Chiefs. The supplements are advertised for weight loss, muscle building, and energy boosting and have been tied to liver injury and recalled in the United States.
The Health Chiefs (similar to the Surgeon General in the U.S.) announced that the OxyElite Pro products and Versa-1 must be pulled from store shelves and medical help should be sought by anyone who has taken the supplement, according to Independent.ie. The Irish Medicines Board (IMB) and the Food Safety Authority Ireland (FSAI) named OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, OxyElite Pro Super Thermo powder, and Versa-1 as the involved products.
John Lynch, IMB Director of Compliance, told Independent.ie that some of the supplements contained a substance that in the past had them deemed 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 noted.
The OxyElite and Versa-1 products have been tied to severe liver disorders, such as hepatitis and liver failure. Ireland reports one case, according to Independent.ie. In the United States, a larger number of cases has been reported, including one death, as well as cases in which liver transplants have been required.
The Director of Consumer Protection at the FSAI, Ray Ellard, stated that online retailers have been advised to cease selling the 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.
In the United States, 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. The recall followed an FDA letter stating OxyElite Pro products were associated with liver illnesses and there was a reasonable probability that the products are adulterated. The agency also indicated that if USPlabs did not implement a voluntary recall, the FDA could mandate the supplement maker to cease distributing the product and advise other parties to stop distributing the products, as well.
The November 6th agency letter discussed findings concerning an association between use of the recalled OxyElite Pro products and liver illnesses reported in Hawaii, and that other cases of liver damage had been reported following use of the recalled OxyElite Pro products in other states. In fact, a review of 46 medical records submitted to the agency by the Hawaii Department of Health revealed that 27 patients—58 percent—had taken a dietary supplement labeled as OxyElite Pro prior to falling ill. Of these, 27 patients—63 percent—reported that OxyElite Pro was the only dietary supplement they had taken.