title: Hepatotoxicity associated with weight loss or sports dietary supplements, including OxyELITE Pro™ - United States, 2013.
abstract: In September 2013, the Hawaii Department of Health (HDOH) was notified of seven adults who developed acute hepatitis after taking OxyELITE Pro™, a weight loss and sports dietary supplement. CDC assisted HDOH with their investigation, then conducted case-finding outside of Hawaii with FDA and the Department of Defense (DoD). We defined cases as acute hepatitis of unknown etiology that occurred from April 1, 2013, through December 5, 2013, following exposure to a weight loss or muscle-building dietary supplement, such as OxyELITE Pro™. We conducted case-finding through multiple sources, including data from poison centers (National Poison Data System [NPDS]) and FDA MedWatch. We identified 40 case-patients in 23 states and two military bases with acute hepatitis of unknown etiology and exposure to a weight loss or muscle building dietary supplement. Of 35 case-patients who reported their race, 15 (42.9%) reported white and 9 (25.7%) reported Asian. Commonly reported symptoms included jaundice, fatigue, and dark urine. Twenty-five (62.5%) case-patients reported taking OxyELITE Pro™. Of these 25 patients, 17 of 22 (77.3%) with available data were hospitalized and 1 received a liver transplant. NPDS and FDA MedWatch each captured seven (17.5%) case-patients. Improving the ability to search surveillance systems like NPDS and FDA MedWatch for individual and grouped dietary supplements, as well as coordinating case-finding with DoD, may benefit ongoing surveillance efforts and future outbreak responses involving adverse health effects from dietary supplements. This investigation highlights opportunities and challenges in using multiple sources to identify cases of suspected supplement associated adverse events. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
authors.affiliation: EIS officer, 1600 Clifton Road NE MS C-09, Atlanta, GA.|Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Kevin
authors.initials: K
authors.lastname: Chatham-Stephens
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Ethel
authors.initials: E
authors.lastname: Taylor
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Arthur
authors.initials: A
authors.lastname: Chang
authors.affiliation: Division of Integrated Biosurveillance, Armed Forces Health Surveillance Center.
authors.forename: Amy
authors.initials: A
authors.lastname: Peterson
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Johnni
authors.initials: J
authors.lastname: Daniel
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Colleen
authors.initials: C
authors.lastname: Martin
authors.affiliation: Department of Military and Emergency Medicine, Uniformed Services University.
authors.forename: Patricia
authors.initials: P
authors.lastname: Deuster
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Noe
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Kieszak
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Josh
authors.initials: J
authors.lastname: Schier
authors.affiliation: Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, Food and Drug Administration.
authors.forename: Karl
authors.initials: K
authors.lastname: Klontz
authors.affiliation: Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention.
authors.forename: Lauren
authors.initials: L
authors.lastname: Lewis
mesh_terms: D000328:Adult; D045930:Anabolic Agents / Q000633:toxicity*; D019440:Anti-Obesity Agents / Q000633:toxicity*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology* / Q000473:pathology / Q000628:therapy; D019587:Dietary Supplements / Q000633:toxicity*; D005260:Female; D006505:Hepatitis / Q000209:etiology* / Q000473:pathology / Q000628:therapy; D006760:Hospitalization; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D045930:Anabolic Agents; D019440:Anti-Obesity Agents
keywords: OxyELITE Pro; Supplement; hepatitis