November 15 2013:Unauthorized weight loss products OxyElite Pro linked to multiple reports of serious liver injury in the U.S.

Health Canada is advising Canadians of a U.S. Food and Drug Administration (FDA) warning not to use dietary supplements labelled as “OxyElite Pro” following several U.S. reports of serious liver injury. Certain OxyElite Pro dietary supplements are being recalled by the distributor, USPLabs LLC of Dallas, Texas (see list below).

OxyElite Pro products, which are promoted for rapid weight loss, are not authorized in Canada and have not been found on the Canadian market. However, they are widely available in the U.S. and over the Internet. Canadians may have purchased these products while shopping online or travelling. The affected products are: OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder.

To date, no adverse reactions have been reported to Health Canada involving OxyElite Pro, however, several dozen U.S. cases of liver damage have so far been potentially linked to OxyElite Pro. These include at least one case resulting in a liver transplant, and one death. Symptoms of liver injury can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

The U.S. FDA and the Centre for Disease Control are continuing their investigation regarding OxyElite and the reports of hepatic adverse reactions.

What you should do

•&nbsp&nbsp&nbsp&nbspDo not use OxyElite Pro products and consult with a healthcare professional if you experience symptoms of liver injury or other health concerns related to their use.

•&nbsp&nbsp&nbsp&nbspContact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find OxyElite Pro products in the Canadian marketplace.

•&nbsp&nbsp&nbsp&nbspUse only health products that have been evaluated by Health Canada for safety, effectiveness, and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.

To report a side effect to a health product to Health Canada:

•&nbsp&nbsp&nbsp&nbspCall toll-free at 1-866-234-2345

•&nbsp&nbsp&nbsp&nbspVisit MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.