Hepatotoxicity associated with weight loss or sports dietary supplements, including OxyELITE Pro™ - United States, 2013.

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.

Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ - Hawaii, 2013.

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.

Use of epidemiological data and direct bioassay for prioritization of affected populations in a large-scale radiation emergency.

Following a radiation emergency, evacuated, sheltered or other members of the public would require monitoring for external and/or internal contamination and, if indicated, decontamination. In addition, the potentially-impacted population would be identified for biodosimetry/bioassay or needed medical treatment (chelation therapy, cytokine treatment, etc.) and prioritized for follow-up. Expeditious implementation of these activities presents many challenges, especially when a large population is affected. Furthermore, experience from previous radiation incidents has demonstrated that the number of people seeking monitoring for radioactive contamination (both external and internal) could be much higher than the actual number of contaminated individuals. In the United States, the Department of Health and Human Services is the lead agency to coordinate federal support for population monitoring activities. Population monitoring includes (1) monitoring people for external contamination; (2) monitoring people for internal contamination; (3) population decontamination; (4) collecting epidemiologic data regarding potentially exposed and/or contaminated individuals to prioritize the affected population for limited medical resources; (5) administering available pharmaceuticals for internal decontamination as deemed necessary by appropriate health officials; (6) performing dose reconstruction; and (7) establishing a registry to conduct long-term monitoring of this population for potential long-term health effects. This paper will focus on screening for internal contamination and will describe the use of early epidemiologic data as well as direct bioassay techniques to rapidly identify and prioritize the affected population for further analysis and medical attention.

Acute selenium toxicity associated with a dietary supplement.

BACKGROUND: Selenium is an element necessary for normal cellular function, but it can have toxic effects at high doses. We investigated an outbreak of acute selenium poisoning. METHODS: A case was defined as the onset of symptoms of selenium toxicity in a person within 2 weeks after ingesting a dietary supplement manufactured by "Company A," purchased after January 1, 2008. We conducted case finding, administered initial and 90-day follow-up questionnaires to affected persons, and obtained laboratory data where available. RESULTS: The source of the outbreak was identified as a liquid dietary supplement that contained 200 times the labeled concentration of selenium. Of 201 cases identified in 10 states, 1 person was hospitalized. The median estimated dose of selenium consumed was 41 749 microg/d (recommended dietary allowance is 55 microg/d). Frequently reported symptoms included diarrhea (78%), fatigue (75%), hair loss (72%), joint pain (70%), nail discoloration or brittleness (61%), and nausea (58%). Symptoms persisting 90 days or longer included fingernail discoloration and loss (52%), fatigue (35%), and hair loss (29%). The mean initial serum selenium concentration of 8 patients was 751 microg/L (reference range, < or =125 microg/L). The mean initial urine selenium concentration of 7 patients was 166 microg/24 h (reference range, < or =55 microg/24 h). CONCLUSIONS: Toxic concentrations of selenium in a liquid dietary supplement resulted in a widespread outbreak. Had the manufacturers been held to standards used in the pharmaceutical industry, it may have been prevented.