{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T02:42:27Z","timestamp":1776825747065,"version":"3.51.2"},"reference-count":39,"publisher":"Wiley","issue":"3-4","license":[{"start":{"date-parts":[[2015,11,2]],"date-time":"2015-11-02T00:00:00Z","timestamp":1446422400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Testing and Analysis"],"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:p>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\u2122 (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\u2010loss\/muscle\u2010building dietary supplement use during the 60 days before illness onset, and residence in Hawaii during the period of exposure. Reported cases\u2019 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\u2010exposed 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\u2010associated hepatotoxicity. The implicated product was OEP. The increasing popularity of dietary supplements raises the potential for additional clusters of dietary supplement\u2010related adverse events. Copyright \u00a9 2015 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/dta.1894","type":"journal-article","created":{"date-parts":[[2015,11,2]],"date-time":"2015-11-02T08:03:52Z","timestamp":1446451432000},"page":"319-327","source":"Crossref","is-referenced-by-count":47,"title":["Hepatotoxicity associated with the dietary supplement OxyELITE Pro\u2122 \u2014 Hawaii, 2013"],"prefix":"10.1002","volume":"8","author":[{"given":"David I.","family":"Johnston","sequence":"first","affiliation":[{"name":"Disease Outbreak Control Division Hawaii Department of Health  Honolulu HI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur","family":"Chang","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa","family":"Viray","sequence":"additional","affiliation":[{"name":"Disease Outbreak Control Division Hawaii Department of Health  Honolulu HI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Chatham\u2010Stephens","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hua","family":"He","sequence":"additional","affiliation":[{"name":"Disease Outbreak Control Division Hawaii Department of Health  Honolulu HI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ethel","family":"Taylor","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda L.","family":"Wong","sequence":"additional","affiliation":[{"name":"The Queen's Medical Center  Honolulu HI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua","family":"Schier","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colleen","family":"Martin","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Fabricant","sequence":"additional","affiliation":[{"name":"Natural Products Association  Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monique","family":"Salter","sequence":"additional","affiliation":[{"name":"Office of Foods and Veterinary Medicine\/Coordinated Outbreak Response and Evaluation Network U.S. Food &amp; Drug Administration  Silver Spring Maryland United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Lewis","sequence":"additional","affiliation":[{"name":"Health Studies Branch, National Center for Environmental Health Centers for Disease Control and Prevention  Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah Y.","family":"Park","sequence":"additional","affiliation":[{"name":"Disease Outbreak Control Division Hawaii Department of Health  Honolulu HI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,11,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2013.2299"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1240006"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jada.2006.12.009"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23937"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2005.08.002"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.138.8.852"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.20204"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2014.159"},{"issue":"62","key":"e_1_2_8_10_1","first-page":"817","article-title":"MMWR Morb","volume":"2013","year":"2013","journal-title":"Mortal. Wkly. Rep."},{"key":"e_1_2_8_11_1","unstructured":"Hawaii Department of Health.Department of Health Investigates Hepatitis Liver Failure in Persons Taking Diet Supplements. Available at:http:\/\/health.hawaii.gov\/news\/files\/2013\/05\/13\u2010055\u2010Department\u2010of\u2010Health\u2010Investigates\u2010Hepatitis\u2010Liver\u2010Failure\u2010in\u2010Persons\u2010Taking\u2010Diet\u2010Suppliments.pdf[13 December 2013]."},{"key":"e_1_2_8_12_1","unstructured":"Haw. Rev. 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Available at:http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/2012\/ucm302167.htm[16 January 2013]."},{"key":"e_1_2_8_20_1","unstructured":"Hawaii Department of Health.Department of Health Requests Voluntary Removal of OxyElite Pro Supplement from Sale. Available at:http:\/\/health.hawaii.gov\/news\/files\/2013\/05\/13\u2010056\u2010DOH\u2010Requests\u2010Voluntary\u2010Removal\u2010of\u2010OxyElite\u2010Pro\u2010From\u2010Sale1.pdf[13 December 2013]."},{"key":"e_1_2_8_21_1","unstructured":"Hawaii Department of Health.Dietary Supplements: Be an Informed Consumer. Available at:http:\/\/health.hawaii.gov\/docd\/files\/2013\/04\/Dietary\u2010Supplements\u2010Factsheet.pdf[19 December 2013]."},{"key":"e_1_2_8_22_1","unstructured":"Hawaii Department of Health.Voluntary Destruction of Embargoed OxyElite Pro Products. 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