title: Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ - Hawaii, 2013.
abstract: Dietary supplements are increasingly marketed to and consumed by the American public for a variety of purported health benefits. On 9 September 2013, the Hawaii Department of Health (HDOH) was notified of a cluster of acute hepatitis and fulminant hepatic failure among individuals with exposure to the dietary supplement OxyELITE Pro™ (OEP). HDOH conducted an outbreak investigation in collaboration with federal partners. Physicians were asked to report cases, defined as individuals with acute onset hepatitis of unknown etiology on or after 1 April 2013, a history of weight-loss/muscle-building dietary supplement use during the 60 days before illness onset, and residence in Hawaii during the period of exposure. Reported cases' medical records were reviewed, questionnaires were administered, and a product investigation, including chemical analyses and traceback, was conducted. Of 76 reports, 44 (58%) met case definition; of these, 36 (82%) reported OEP exposure during the two months before illness. No other common supplements or exposures were observed. Within the OEP-exposed subset, two patients required liver transplantation, and a third patient died. Excessive product dosing was not reported. No unique lot numbers were identified; there were multiple mainland distribution points, and lot numbers common to cases in Hawaii were also identified in continental states. Product analysis found consumed products were consistent with labeled ingredients; the mechanism of hepatotoxicity was not identified. We report one of the largest statewide outbreaks of dietary supplement-associated hepatotoxicity. The implicated product was OEP. The increasing popularity of dietary supplements raises the potential for additional clusters of dietary supplement-related adverse events. Copyright © 2015 John Wiley & Sons, Ltd.
authors.affiliation: Disease Outbreak Control Division, Hawaii Department of Health, Honolulu, HI, USA.
authors.forename: David I
authors.initials: DI
authors.lastname: Johnston
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Arthur
authors.initials: A
authors.lastname: Chang
authors.affiliation: Disease Outbreak Control Division, Hawaii Department of Health, Honolulu, HI, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Viray
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Chatham-Stephens
authors.affiliation: Disease Outbreak Control Division, Hawaii Department of Health, Honolulu, HI, USA.
authors.forename: Hua
authors.initials: H
authors.lastname: He
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Ethel
authors.initials: E
authors.lastname: Taylor
authors.affiliation: The Queen's Medical Center, Honolulu, HI, USA.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wong
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Schier
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Colleen
authors.initials: C
authors.lastname: Martin
authors.affiliation: Natural Products Association, Washington, DC, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Fabricant
authors.affiliation: Office of Foods and Veterinary Medicine/Coordinated Outbreak Response and Evaluation Network, U.S. Food & Drug Administration, Silver Spring, Maryland, United States.
authors.forename: Monique
authors.initials: M
authors.lastname: Salter
authors.affiliation: Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Lewis
authors.affiliation: Disease Outbreak Control Division, Hawaii Department of Health, Honolulu, HI, USA.
authors.forename: Sarah Y
authors.initials: SY
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology*; D019587:Dietary Supplements / Q000009:adverse effects*; D005260:Female; D006254:Hawaii; D006505:Hepatitis / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D017093:Liver Failure / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: dietary supplements; toxic hepatitis