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Copyright © 2017 Natural Medicines (www.naturalmedicines.com)
October 2013

FDA: OxyElite Pro Linked To Non-Viral Hepatitis

The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Hawaii Department of Health (DOH) are investigating reports of non-viral hepatitis that may be linked to OxyElite Pro, a dietary supplement product.

The Hawaii DOH reports that 24 cases of non-viral hepatitis share a common link to OxyElite Pro. This product is distributed by USPLabs LLC in Dallas, Texas, and is sold nationwide through the internet and retail stores. A total of 29 cases of non-viral hepatitis have been reported in the state of Hawaii, with 11 of these cases resulting in hospitalization. Two of the cases have involved liver transplants, and one person has died.

The CDC is currently investigating other liver injury cases nationwide that may be associated with the product. Symptoms of hepatitis may include clay or gray-colored stools, dark urine, fatigue, fever, jaundice, joint pain, nausea, reduced appetite, stomach pain, vomiting, and yellow eyes.

The FDA is reviewing patient medical records and histories, as well as samples of the product that have been collected from some of these individuals. The agency is also inspecting the facilities that manufacture the product and reviewing production and distribution records. The manufacturer, USPLabs LLC, has informed the FDA that it believes that counterfeit OxyElite Pro is being marketed in the U.S. The FDA is investigating whether these counterfeit products may be related to any of the cases of non-viral hepatitis.

The FDA advises people in possession of OxyElite Pro to stop using it immediately during the investigation. Those who believe that they have been affected by a dietary supplement should contact their healthcare practitioner. Both clinicians and patients are advised to report any side effects that may be related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration. www.fda.gov

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