Diet Drug Recalled Due to Potential Liver Damage
The U.S. Food and Drug Administration (FDA) announced this past Sunday that a popular diet drug has been recalled. USPlabs, the company that manufactures OxyElite Pro sports supplement products, announced that it is recalling some of its products after they were linked to causing liver damage. So far, one person has died from it.
Before the voluntary recall, the FDA had sent the Dallas-based company a letter informing the company to issue a recall. The letter stated that if USPlabs did not recall some of its products, the FDA would issue an order to stop the company from distributing its products. The FDA would also inform other retailers and distributors to stop selling USPlabs' products.
"We took this step to ensure that adulterated and harmful products do not reach the American public," Michael Taylor, the FDA Deputy Commissioner said according to USA Today.
The FDA's letter was sent out on November 6 after the agency learned that some of the OxyElite Pro Products were connected to liver disease in Hawaii. The FDA had examined 46 medical records provided to them by the Hawaii Department of Health. The records revealed that 58 percent of the people, or 27 patients, had fallen ill after taking an OxyElite Pro product. Of the 27 patients, 63 percent of them stated that the OxyElite Pro product was the only supplement they used. The FDA has since warned people not to take OxyElite Pro or VERSA-1 labeled supplements.
According to the U.S. Centers for Disease Control and Prevention (CDC), there have been 56 confirmed cases of liver illnesses tied to these products since April 1. The majority of the cases were in Hawaii. As of right now, officials are unsure what is the exact cause of the outbreak.
Just last month, the agency had informed USPlabs that OxyElite Pro and VERSA-1 supplements were considered to be adulterated products. The FDA stated that these products use an ingredient known as aegeine, which is a compound that comes from an Asian tree. The safety of this compound is currently unknown due to the lack of use of this ingredient within the country. The company had fought back against the FDA by sending a letter on November 4. The letter stated that the ingredient has been used safely for centuries. However, due to what the company is calling negative publicity, USPlabs decided to discontinue the use of the ingredient. Now, all of its supplements that were made with aegeline have been destroyed. Their ingredients are being reformulated.
The FDA recommends consumers of these products to see their doctors if they believe that they have been negatively affected by the supplement. Victims can fie a report with the FDA by contacting 1-800-FDA-1088. The recall report can be found on the FDA's website here.