FDA Warning: OxyElite Pro Non-Viral Hepatitis Outbreak in HI

October 8, 2013 — The FDA is investigating a deadly outbreak of non-viral hepatitis (liver inflammation) in Hawaii that has been linked to OxyElite Pro.

The FDA is collaborating with the Centers for Disease Control (CDC) and the Hawaii Department of Health (DOH). Hawaiian health officials have linked 24 illnesses (83%) to OxyElite Pro. The agencies are also investigating other reports of liver injury throughout the United States that may be related to this outbreak.

The FDA warned:

“There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state of Hawaii.  Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died.”

All of the victims were previously healthy before using OxyElite Pro, a dietary supplement that is commonly used for weight-loss of bodybuilding. The patients sought medical care from May through September 2013.

Counterfeit OxyElite Pro to Blame?

USPLabs, LLC, the manufacturer of OxyElite Pro, has warned that counterfeit products have been on the market and they could be related to the cases of acute hepatitis. The FDA is investigating whether counterfeit products are associated with the outbreak. In the meantime, USPLabs has voluntarily stopped selling OxyElite Pro. However, they have not issued any recalls.

Symptoms of Acute Non-Viral Hepatitis

Symptoms of acute, non-viral hepatitis (liver inflammation) may appear very rapidly, often within a matter of days. According to the CDC, the most commonly-reported symptoms were loss of appetite, dark-colored urine, light-colored stools, and jaundice.

Symptoms of acute non-viral hepatitis:

  • Fever
  • Fatigue
  • Loss of appetite
  • Nausea
  • Vomiting
  • Abdominal pain
  • Dark urine
  • Clay or gray-colored stools
  • Joint pain
  • Jaundice (yellow skin, eyes)

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