The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro.
BACKGROUND: OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nationwide through internet and retail stores that sell dietary supplements.
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. CDC is also looking at other cases of liver injury nationwide that may be related. Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.
The investigation is being conducted by the Hawaii DOH and the CDC. As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their healthcare practitioner.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Ten patients had liver biopsy data available at the time of this report. Seven had histology consistent with hepatitis from drug/toxic injury.. Three patients had liver biopsy findings of acute hepatitis associated with other etiologies such as autoimmune hepatitis. Eleven patients were hospitalized, with a median duration of seven days. One patient died, and two patients received liver transplants. Two remain hospitalized, and all other hospitalized patients have been discharged.
Of the 29 identified patients, 24 reported using OxyELITE Pro during the 60 days prior to illness onset. There was no other dietary supplement or medication use reported in common by more than two patients.
National case finding efforts have identified several individuals from states outside Hawaii with reported OxyELITE Pro or other weight loss or muscle building dietary supplement use prior to the development of acute hepatitis of unknown cause. CDC, in collaboration with state health departments, is collecting additional information from these individuals to determine if this outbreak is national in scope.
USPlabs LLC has agreed to stop distributing its energy and-fat burning supplement OxyElite Pro after Hawaii officials have linked it to 24 cases of acute non-viral hepatitis, FDA announced Tuesday.
Maui resident Jeanette Kaipo told the Honolulu Star-Advertiser that her 48-year-old sister Sonnette Marras died last week after taking OxyElite Pro for several weeks to lose weight that she gained during her last pregnancy.
The reported illnesses and epidemiological probe represent another setback for USPlabs, whose products containing a stimulant known as DMAA have been linked to more than 100 illnesses including six deaths.
Dallas-based USPlabs has told the press it stands by its product, which is distributed online and at retail stores.
"The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market," the company said in a statement released to the Honolulu Star-Advertiser. "We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues."
