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 trace back, 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.

Herbal and Dietary Supplement–Induced Liver Injury

“…(24, 77) Following this report, other cases were identified in an outbreak investigation performed by the Hawaii Department of Health, Centers for Disease Control and Prevention (CDC) and FDA. (77) The product was recalled and the manufacturer was required to discontinue the distribution of OxyELITE Pro. (18) Aegeline, derived from the bark of the Bael tree in India, has long been used as a traditional remedy but the component implicated in the OxyELITE Pro outbreak was synthetic.…”

“…(76) Early reports of liver injury were from Hawaii, where an initial cluster of 7 patients was reported to develop liver injury in the period between May and September 2013. (24, 77) Following this report, other cases were identified in an outbreak investigation performed by the Hawaii Department of Health, Centers for Disease Control and Prevention (CDC) and FDA. (77) The product was recalled and the manufacturer was required to discontinue the distribution of OxyELITE Pro.…”

Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series

“…However, all of the DILIN cases occurred in the continental US in comparison to the larger outbreak that was reported primarily in Hawaii. An investigation of the Hawaii cases failed to demonstrate a common batch or expiration date of the OxyELITE Pro product that was consumed (26). The DILIN cases tended to have more severe outcomes, including a higher rate of hospitalization (86% vs. 38%) and liver transplant or death (29% vs. 10%), which may relate to ascertainment and/or referral bias.…”

Emergency department visits and hospitalisations for adverse events related to dietary supplements are common

“…All supplements are presumed to be safe. However, prior research has found that individual supplements can pose serious health risks 2 3. This study was the first attempt to estimate the number of consumers in the USA who require emergency department (ED) visits or hospitalisations due to supplement adverse events.…”