The Hawaii Department of Health (DOH) and U.S. Food & Drug Administration (FDA) are warning the public to stop using OxyElite Pro, a popular pre-workout dietary supplement, after it was linked to nearly 30 cases of acute hepatitis and liver failure, including one death. As a result of these problems, health authorities have issued a nationwide OxyElite Pro recall, and requested that retailers stop selling the product. USPlabs LLC, the company that makes OxyElite Pro, has informed the FDA that they will voluntarily halt production and distribution of the product until the investigation into the matter can be completed.
OxyElite Pro Lawsuit Update 4/16/14: Earlier this month, a panel of federal judges denied a motion by the makers of OxyElite Pro and Jack3d to transfer and consolidate a number of products liability lawsuits to federal court in Philadelphia. The litigation contends that the supplements contained altered ingredients that were unsafe and unapproved by the FDA, leading to a nationwide hepatitis outbreak. Click here to learn more.
Free OxyElite Pro Lawsuit Evaluation: If you or a loved one has developed liver damage, liver failure, or hepatitis after taking OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of OxyElite Pro and we can help.
What’s the Problem?
In response to the reports of hepatitis and liver failure associated with OxyElite Pro in Hawaii, the FDA has stated that it is investigating whether counterfeit versions of the supplement (which are believed to be widely available) were related to any of the cases. USPlabs said in a statement that “the cluster of liver issues in Hawaii is a complete mystery” and that all the company’s products are safe to use as directed.
Last year, the FDA issued a warning to companies who manufactured products containing dimethylamylamine, or DMAA, which stated that they needed to be pulled off the market immediately or reformulated without the ingredient. USPlabs received the warning letter because two of its products (OxyElite Pro and Jack3d) contained DMAA.
The FDA is currently in the process of determining whether the OxyElite Pro associated with the hepatitis and liver damage cases in Hawaii was the older, DMAA-containing variety or the new formulation. USPlabs said OxyElite Pro hasn’t been manufactured or sold with DMAA since early this year, and that production and distribution of the newer formulation has been discontinued until the investigation can be completed.
According to the Hawaii Department of Health, 24 out of 29 patients under investigation reported using OxyElite Pro before suffering injuries. All cases of acute hepatitis and liver failure occurred between May and October. The median age of the patients is 33, and 14 are male, according to the Centers for Disease Control and Prevention. At least two of these individuals underwent liver transplant procedures. Eleven required emergency hospitalization, and two remain hospitalized.
“National case finding efforts have identified several individuals from states outside Hawaii with reported OxyELITE Pro or other weight loss or muscle building dietary supplement use prior to the development of acute hepatitis of unknown cause,” the CDC stated in a health advisory. “CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these individuals to determine if this outbreak is national in scope.”
Last week, Sonnette Marras died after using OxyElite Pro to lose weight gained during her last pregnancy. The 48-year-old Maui resident had seven children, ranging in age from 1 to 26.
Do I have an OxyElite Pro Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro Lawsuits. We are handling individual litigation nationwide and currently accepting new OxyElite Pro liver damage, liver failure, and hepatitis cases in all 50 states.
Free OxyElite Pro Lawsuit Evaluation: If you or a loved one has developed liver damage, liver failure, or hepatitis after taking OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing an OxyElite Pro suit and we can help.