The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement

Public Health Reports
Karl C KlontzKathleen Gensheimer

Abstract

Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE Pro(TM), a dietary supplement used for weight loss and/or muscle building. Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formu...Continue Reading

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Citations

Apr 14, 2016·International Journal of Molecular Sciences·Miren García-CortésRaul J Andrade
May 5, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Philip SargesJames H Lewis
Dec 14, 2016·AACN Advanced Critical Care·Leslie A HamiltonRachel E Collins
Feb 18, 2017·Digestive Diseases and Sciences·Rolf Teschke, Axel Eickhoff
Jun 20, 2018·Clinical Pharmacology and Therapeutics·Marina M RoytmanVictor Navarro
Apr 5, 2016·International Journal of Molecular Sciences·Rolf Teschke, Axel Eickhoff
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