A controversial diet supplement linked to liver damage and hepatitis has been recalled.
Earlier this week, the Food and Drug Administration announced that Dallas-based USPlabs is recalling certain OxyElite Pro sports supplement products – used for muscle building and weight loss – linked to an outbreak of liver illnesses. The recall follows a letter from the FDA which notified the manufacturer that if it did not recall the supplements voluntarily, the agency would order the company to stop distribution of the products.
After linking the products to dozens of hepatitis and liver failure incidents in Hawaii, investigators traced the pills to cases in other states as well. ABC News Reports
The Centers for Disease Control and Prevention said it had confirmed 56 cases of liver illnesses since April 1 in the outbreak. Products covered by the recall include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Super Thermo Powder. The products are sold for weight loss.
In the letter to USPlabs, the FDA told the company that a review of liver illnesses reported in Hawaii indicate a connection to the OxyElite Pro products. The FDA’s review of 46 medical records provided by the Hawaii Department of Health indicated that 27 patients — 58% — had taken an OxyElite Pro product before they became ill. Of those 27 patients who had taken OxyElite Pro, 63% said it was the only supplement they used. USA Today Report
The supplement first came under fire two years ago. At the time OxyElite Pro and other fitness supplements that contained a stimulant called DMAA were pulled from military shelves – following the collapse and death of three soldiers during training at Fort Bliss, Texas.
The FDA continues to warn consumers not to take any supplements labeled OxyElite Pro or VERSA-1. The agency said consumers who think they have been harmed should contact a doctor and can file a report with the FDA by calling 1-800-FDA-1088.