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BACKGROUND: Dietary supplements are increasingly marketed to and consumed by the American public for a variety of purported health benefits. On September 9, 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 popular dietary supplement OxyELITE ProTM (OEP).
METHODS: Physicians were asked to report cases, defined as individuals with acute onset hepatitis of unknown etiology on or after April 1, 2013 and a history of weight-loss/muscle-building dietary supplement use during the 60 days before illness onset. HDOH conducted an investigation in collaboration with federal partners.
RESULTS: Of 76 reports, 44 (58%) met the 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; one patient died. Median time from initial exposure to onset was 62 days (range 7–732, n=31). Median duration of symptoms was 33 days (range 1–128, n=14). 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.
CONCLUSIONS: We report one of the largest outbreaks of dietary supplement-associated hepatotoxicity. The implicated product was OxyELITE ProTM. The increasing popularity of dietary supplements that currently undergo minimal pre-market safety and efficacy evaluation relative to medications raises the potential for additional clusters of dietary supplement-related adverse events.