The fat-burning supplement OxyElite Pro has been linked to an epidemic of liver damage. In October 2013, health officials in Hawaii reported 29 cases of acute non-viral hepatitis (liver inflammation), including 11 hospitalizations, two liver transplants, and 1 death. FDA and CDC officials are now investigating cases of liver damage in other states.
Free OxyElite Pro Liver Damage Lawsuit Evaluation: If you or your loved one was injured by OxyElite Pro, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
OxyElite Pro Recall
November 10, 2013 – OxyElite Pro has been recalled, according to this announcement from the FDA and USPLabs, LLC, the manufacturer of OxyElite Pro. The products have been linked to liver damage.
Products included in OxyElite Pro recall:
- OxyElite Pro Super Thermo Capsules
- OxyElite Pro Ultra-Intense Thermo Capsules
- OxyElite Pro Super Thermo Powder
As of October 31, health officials have identified 56 cases of liver damage from OxyElite Pro, including 22 people who were hospitalized, two people who needed liver transplants, and one person who died. According to the FDA:
“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.”
What is OxyElite Pro?
OxyElite Pro is a dietary supplement that is sold by USPLabs, LLC, a company that is based in Dallas, Texas. USPLabs is no stranger to controversy — for years, they sold OxyElite Pro with an illegal stimulant ingredient called DMAA, while claiming it was derived from the geranium plant. After DMAA was linked to cardiovascular side effects, USPLabs re-formulated OxyElite Pro and sold it without DMAA under the following brand-names:
- OxyElite Pro with the “Purple Top”
- OxyElite Pro Super Thermo Powder
What’s the problem?
Because OxyElite Pro is a dietary supplement, it has never been evaluated by the FDA for safety. The FDA’s authority over dietary supplements is very different from food or drugs. If a supplement is unsafe, the FDA must undertake a lengthy scientific and legal procedure to remove the product from the market. For example, it took the FDA over a year to force USPLabs to destroy $8 million worth of DMAA-containing OxyElite Pro. By that time, thousands of people had taken the products, and at least 86 injuries were reported.
Hawaii OxyElite Pro Liver Damage Outbreak Investigation
In September 2013, the Hawaii Department of Health (DOH) received reports of 7 patients who had hepatitis and sudden liver failure after taking OxyElite Pro. The patients were previously healthy and had no risk-factors for liver failure except OxyElite Pro.
By October, doctors reported 29 liver injuries in patients who previously used a dietary supplement. Of those, 24 people (83%) reported using OxyElite Pro. Doctors who treated the patients noticed severely elevated liver enzyme levels in blood tests (4X the upper-limit of normal), which is an indication of liver damage.
10 patients had biopsies taken of liver tissue, which showed tissue necrosis and cholestasis (obstruction of the bile duct). Eleven patients (38%) were hospitalized for an average of 7 days. Two patients required liver transplants. One woman died because she was not eligible for a liver transplant due to breast cancer.
On October 8, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication to announce that they would investigate the outbreak, including possible counterfeit OxyElite Pro, and partner with the CDC to investigate cases of liver damage in other states.
What is Liver Damage?
The liver is responsible for filtering toxins and waste products from your blood. About 80% of the total mass of the liver is hepatocytes, which are special cells that convert poisonous substances into harmless chemicals that can be excreted in urine or bile. Liver damage occurs when a significant number of hepatocytes are destroyed, leading to acute or chronic inflammation (or “non-viral hepatitis”).
Symptoms of Liver Damage
The symptoms of acute non-viral hepatitis often develop rapidly. Without treatment, hepatitis can cause sudden liver failure. According to the Centers for Disease Control (CDC), the most common reported symptoms of liver damage in people who used OxyElite Pro include:
- Loss of appetite
- Light-colored stools
- Dark-colored urine
- Jaundice (yellow eyes and skin)
- Nausea, vomiting
- Abdominal pain (upper-right side)
- Elevated liver enzymes in blood tests
Complications of Liver Damage
Most healthy adults who have minor liver damage can recover without permanent complications. The liver can heal and recover from minor injuries. However, when the liver heals, it forms scar tissue. A small amount of scar tissue (called fibrosis) permanently damages liver function, but it is not life-threatening. Cirrhosis occurs when a large amount of scar tissue prevents the liver from functioning, leading to liver failure. Another serious complication is hepatic encephalopathy, which can cause permanent brain damage and death.
Do I have an OxyElite Pro Liver Damage 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 cases in all 50 states.
Free OxyElite Pro Liver Damage Lawsuit Evaluation: Again, if you or a loved one was injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and our lawyers can help.