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FDA Warning for Non-Viral Hepatitis Outbreak in HI

FDA Warning for Non-Viral Hepatitis Outbreak in HI

October 8, 2013 — The FDA has published a Safety Communication for OxyElite Pro. The dietary supplement has been linked to at least 24 cases of acute, non-viral hepatitis in Hawaii from May through September 2013.

The FDA will partner with Hawaiian Department of Health (DOH) and the Centers for Disease Control (CDC) to investigate the outbreak. Because the federal government is shut down, the FDA and CDC have been forced to recall epidemiologists who were furloughed.

OxyElite Pro was sold throughout the United States, and officials are now investigating whether liver injuries in other states are related to the outbreak. No recall has been issued, but the manufacturer has agreed to stop selling OxyElite Pro during the investigation.

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.”

Counterfeit OxyElite Pro Sold in United States for “Some Time”

USPLabs, the manufacturer of OxyElite Pro, is no stranger to the FDA. Since April 2012, the FDA has been working to remove OxyElite Pro from the market because it contained DMAA, an illegal stimulant drug. Earlier this year, USPLabs agreed to re-formulate their product and voluntarily destroyed over $8 million worth of the supplement.

USPLabs warned that FDA that counterfeit OxyElite Pro has been sold in the United States for “some time,” and these products may be responsible for the outbreak of hepatitis. While the FDA investigates, USPLabs has agreed to stop selling OxyElite Pro. However, they have not issued a recall.

Symptoms of Non-Viral Hepatitis

Victims of the non-viral hepatitis outbreak have reported symptoms that appeared very suddenly, within a matter of days. In this outbreak, the CDC reports that most of the victims developed dark-colored urine, light-colored stools, jaundice, and loss of appetite.

Acute non-viral hepatitis symptoms:

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

Do I have an OxyElite Pro Lawsuit?

The Schmidt Firm, PLLC is currently accepting OxyElite Pro induced injury cases in all 50 states. If you or somebody you know has been injured by OxyElite Pro, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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