After receiving warning letters from the FDA for violation of federal drug safety laws, USPlabs agreed to recall the entire OxyELITE Pro line on November 9. In its press release announcing the recall, USPlabs stated:
“Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.”
In a warning letter issued on October 11, 2013, the FDA informed USPlabs that OxyELITE Pro and VERSA-1, another dietary supplement, were deemed to be adulterated because they contain aegeline.
The FDA letter explained that USPlabs failed to provide sufficient evidence of safety regarding aegeline. Andrews observes, “Once again, USPlabs introduced a dietary supplement formulation without a historic safety record with disastrous consequences.”
State and federal health authorities continue to investigate the mounting number of cases of previously healthy adults who developed acute hepatitis and sudden liver failure after taking OxyELITE Pro. On September 9, 2013, the Hawaii Department of Health (HDOH) began an investigation of seven patients with acute hepatitis and fulminant liver failure after taking OxyELITE Pro, which is used for weight loss and/or muscle gain. The Centers for Disease Control (CDC) joined the investigation. On October 8, 2013, the FDA issued a public health alert, reporting 24 cases of liver injury linked to OxyELITE Pro. Since then, dozens of people have been diagnosed with liver illness linked to the dietary supplement, and one person died.
Attorney Anne Andrews, who has a national reputation for her work on behalf of consumers injured by unsafe dietary supplements, has verified that the liver failure outbreak is national in scope:
“We first received information about cases from Hawaii, where all patients were treated at Queens Medical Center. The physicians at Queens were very thorough in their investigation and discovered the culprit was OxyELITE Pro. We have since been contacted by users of OxyELITE Pro from several states whose physicians have confirmed the diagnosis of supplement-induced fulminant liver failure.”
News of this liver illness outbreak arrives months after the former version of OxyELITE Pro, which was linked to serious cardiovascular injuries and death, was removed from the market. Andrews and Thornton was in active litigation against USPlabs over the earlier product when the liver injuries were discovered. The firm represents numerous victims of liver injury from the new OxyELITE Pro.
Just last year, USPlabs received a warning letter from the FDA regarding a former version of OxyELITE Pro and Jack3d because the dietary supplements contained DMAA, a dangerous drug ingredient banned by the FDA. However, it was not until August 2013 that USPlabs finally agreed to destroy all remaining products containing DMAA. Although the new formulation of OxyELITE Pro does not contain DMAA, the dietary supplement continues to cause serious, and sometimes fatal, injuries.
The OxyELITE Pro recall includes the following products:
- OxyELITE Pro Super Thermo capsules
- OxyELITE Pro Ultra-Intense Thermo capsules
OxyELITE Pro Super Thermo Powder
If you or a loved one has been harmed by OxyELITE Pro, please contact us immediately for a free case evaluation at 800-664-1734 or www.andrewsthornton.com.