Outbreak of severe hepatitis linked to weight-loss supplement OxyELITE pro

American Journal of Gastroenterology

Volumn 109, Issue 8, 2014, Pages 1296-1298

  Roytman, Marina M ^a,b   Pörzgen, Peter ^a   Lee, Christine L ^b   Huddleston, Leslie ^a   Kuo, Timothy T ^a   Bryant Greenwood, Peter ^a   Wong, Linda L ^b   Tsai, Naoky ^a,b  

^a QUEEN S MEDICAL CENTER   (United States)

^b UNIVERSITY OF HAWAII   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AMIDES; BIOPSY; DIETARY SUPPLEMENTS; DRUG-INDUCED LIVER INJURY; FEMALE; HUMANS; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; UNITED STATES; WEIGHT LOSS;

EID: 84905492825     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2014.159     Document Type: Letter

References (16)

1. Ogden CL, Carrol MD, Kit BK et al. Prevalence of obesity in the United States, 2009-2010. NCHS data brief, no 82. Hyattsville, MD: National Center for Health Statistics, 2012. DHHS Publication No. (PHS) 2012-1209.
2. Timbo BB, Ross MO, McCarthy PV et al. Dietary supplements in a national survey: prevalence of use and reports of adverse events. J Am Diet Assoc 2006; 106 : 1966-74.
3. Navarro VJ, SeeffLB. Liver injury induced by herbal complementary and alternative medicine. Clin Liver Dis 2013; 17 : 715-35.
4. Bunchorntavakul C, Reddy KR. Review article: herbal and dietary supplement hepatotoxicity. Aliment Pharmacol Ther 2013; 37 : 3-17.
5. Teschke R, WolffA, Frenzel C et al. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int 2012; 32 : 1543-56.
6. Regulatory Information. Dietary Supplement Health and Education Act of 1994. US Food and Drug Administration. http://www.fda. gov/ regulatoryinformation/legislation/federal fooddrugandcosmeticactfdcact/signifi cant amendmentstothefdcact/ucm148003.htm, last accessed on 30 December 2013.
7. Dietary Supplements. US Food and Drug Administration. http://www.fda.gov/food/dietarysupplements/default.htm, last accessed on 30 December 2013.
8. Lammie J (Ed) and safety panel lead. Report of the Department of Defense 1,3-dimethylamylamine (DMAA) safety review panel. 2013, 97-8. http://home.fh pr.osd.mil/Libraries/pdf/Report-of-the-DoD-DMAA-Safety-Review-Panel-2013.sfl b.ashx, last accessed on 30 December 2013.
9. Eliason MJ, Eichner A, Cancio A et al. Death of active duty soldiers following ingestion of dietary supplements. Mil Med 2012; 177 : 1455-9.
10. Gee P, Tallon C, Long N et al. Use of recreational drug 1,3-dimethylamine (DMAA) associated with cerebral hemorrhage. Ann Emerg Med 2012; 60 : 431-4.
11. Response Letter to USP Labs LLC Concerning DMAA. U.S. Food and Drug Administration, 18 April 2013. http://www.fda.gov/aboutfda/centersoffices/ officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm350199.htm, last accessed on 31 December 2013.
12. Fontana RJ, Watkins PB, Bonkovsky HL et al. Drug-Induced Liver Injury Network (DILIN) prospective study rationale, design and conduct. Drug Safety 2009; 32 : 56-68.
13. Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to druginduced liver injuries. J Clin Epidemiol 1993; 46 : 1323-30.
14. Acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building. CDCHAN-00356. Distributed via the CDC Health Alert Network. 8 October 2013 http://emergency.cdc.gov/HAN/han00356.asp, last accessed on 30 December 2013.
15. Warning Letter (Usp Labs 11/10/13). U.S. Food and Drug Administration, 11 October 2013. http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ ucm371203.htm, last accessed on 31 December 2013.
16. OxyElite Pro Supplements Recalled. FDA Consumer Health Information. Consumer Updates November 2013. U.S. Food and Drug Administration http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm374742. htm, last accessed on 30 March 2014.