OxyElite Pro Linked to Severe Liver Damage
On November 10, 2013, the FDA officially announced the recall of popular dietary supplement OxyElite Pro because of the product’s link to severe liver damage in users.
Many dietary supplements like OxyElite and sports performance enhancers were manufactured with the active ingredient of dimethylamine (DMAA). This past summer, the FDA released an official warning against this ingredient, announcing that any dietary supplement containing this ingredient is now illegal. It has also been banned by several professional sports associations, including Major League Baseball, as it has been categorized as a highly toxic performance enhancer.
This ban in the U.S. affected many dietary supplement manufacturers, including USPlabs, LLC, the creator and distributor of OxyElite Pro and other similar products. In July of 2013, USPlabs destroyed over $8 million dollars worth of product containing this dangerous additive to comply the FDA. However, the DMAA needed to be replaced with something similar in order to achieve the same results. Aegeline, a compound from a tree found in Asia, was added to OxyElite Pro. This compound had not been seen in the U.S. before 1994 and has had no history of use here or proof that it is safe when ingested by humans.
In October of 2013, the FDA issued a warning letter to USPlabs, stating that the products OxyElite Pro and the similar VERSA-1 were deemed adulterated because of the addition of the virtually unknown substance aegeline.
On November 6, 2013, the FDA issued another statement to USPlabs telling the manufacturing company that if they did not issue an immediate and nationwide recall of OxyElite Pro, the FDA would take legal action to stop the distribution and sale of the supplement. This order came as a result of a study of 46 medical records of patients with liver conditions. Of the 46 patients, 27, or 58%, reported using OxyElite Pro before they became ill. Seventeen (17) of those twenty-seven (27) patients, or 63%, reported that OxyElite Pro was the only dietary supplement they used prior to becoming ill. Twenty-nine (29) cases of liver failure and hepatitis have been reported in Hawaii in October 2013 alone. So far, one person has died from the liver damage, one has received a liver transplant, and others await their transplants.
While the company staunchly stands by the safety of their products, USPlabs decided to issue the recall themselves while the FDA released an official recall. The products that have been officially recalled from store shelves nationwide include:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Ultra Intense Thermo capsules
- OxyElite Pro Super Thermo powder
To see the complete list of OxyElite Products recalled, click here.
The FDA has and continues to warn consumers to stop taking OxyElite products immediately while the investigation into its safety is underway.
If you have or are taking OxyElite Pro and develop any of the following symptoms, please contact your physician immediately:
- Loss of appetite
- Abdominal pain
- Yellow skin or eyes
- Nausea or vomiting
If you or someone you love has been affected by OxyElite Pro or VERSA-1, you may be entitled to compensation. Our team of pharmaceutical attorneys has successfully handled lawsuits on behalf of clients who have been injured by Fen-Phen, Rezulin, Propulsid, Gadolinium, Ortho Evra, Vioxx, Phenylpropanolamine (PPA), and many other drugs and medical devices, including transvaginal mesh.
Contact us online or call us at 800-829-7037 for a free and confidential legal consultation.