OxyELITE Pro Supplement Lawsuit
A dietary supplement known as DMAA contained in the products OxyELITE Pro and Jack3d, which is used by athletes as an energy booster has raised safety concerns, concerns heightened with news of recent deaths and liver failures of people throughout the country and US soldiers stationed overseas.
The stimulant, dimethylamylamine (DMAA), sold over the counter in stores such as GNC and Vitamin Shoppe, can elevate blood pressure and could lead to cardiovascular problems, according to an April 2013 warning issued by the U.S. Food and Drug Adminsitration. The FDA later ordered maker USPlabs to destroy all inventories of the products.
The FDA Orders a Recall of OxyELITE Pro
Recently, additional concerns about these supplements have come to light. Specifically, the use of OxyElite Pro has allegedly been linked to hepatitis and liver failure in people throughout the country. What was initially thought to be a situation affecting only Hawaii purchases has proven to be much more widespread. In fact, by a letter dated November 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of OxyElite Pro products and a number of liver illnesses reported in Hawaii and also noted that cases of liver damage after use of these products had been found in a number of other states. (Read the FDA Notification).
The FDA notification regarding OxyElite Pro
In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.
In a warning letter that the FDA issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action. In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
OxyELITE Pro Jack3d, and DMAA Supplement Defect Lawyers
Consumers who believe they have been harmed by using a dietary supplement should contact their healthcare practitioner. After contacting your doctor, you should immediately contact an OxyELITE Pro Lawyer to discuss your potential OxyELITE Pro, Jack3d and DMAA injury.