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

Overview

Journal Dig Dis Sci

Specialty Gastroenterology

Date 2016 May 5

PMID 27142670

Citations 17

Authors

Lauren A Heidemann

Victor J Navarro

Jawad Ahmad

Paul H Hayashi

Andrew Stolz

David E Kleiner

Robert J Fontana

Affiliations

Soon will be listed here.

Abstract

Background/aim: Herbal and dietary supplement (HDS) hepatotoxicity is increasingly being reported in the USA. This case series describes the presenting clinical features and outcomes of seven patients with liver injury attributed to OxyELITE Pro enrolled in the Drug-Induced Liver Injury Network (DILIN) study.

Methods: The 6-month outcomes of patients with hepatotoxicity attributed to OxyELITE Pro enrolled in the DILIN prospective registry between 2004 and 2015 are presented.

Results: Six of the seven patients (86 %) presented in 2013 with symptoms of hepatitis and acute hepatocellular injury. The median duration of OxyELITE Pro use was 18 weeks (range 5-102 weeks). Median age was 36 years (range 28-62), 86 % were female, and 43 % were Asian. One patient had rash, none had eosinophilia, and three had antinuclear antibody reactivity. The median peak ALT was 2242 U/L, alkaline phosphatase 284 U/L and bilirubin 15.0 mg/dL. Six patients (86 %) were hospitalized, three developed acute liver failure and two underwent liver transplantation. DILIN causality scores for OxyELITE Pro were definite in 1, highly likely in 3, probable in 2, and possible in 1. Four of the five patients without liver transplant recovered completely within 6 months, while one patient had mild residual ALT elevations.

Conclusions: Seven cases of severe acute hepatocellular injury attributed to OxyELITE Pro are reported. These results reinforce the need to assess for HDS supplement use in patients presenting with unexplained acute hepatitis and point to the need for additional regulatory oversight of HDS products.

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References

Navarro V, Bonkovsky H, Hwang S, Vega M, Barnhart H, Serrano J . Catechins in dietary supplements and hepatotoxicity. Dig Dis Sci. 2013; 58(9):2682-90. PMC: 3769469. DOI: 10.1007/s10620-013-2687-9. View

Martin D, Partridge B, Shields W . Hepatotoxicity associated with the dietary supplement N.O.-XPLODE. Ann Intern Med. 2013; 159(7):503-4. DOI: 10.7326/0003-4819-159-7-201310010-00019. View

Lambert J, Kennett M, Sang S, Reuhl K, Ju J, Yang C . Hepatotoxicity of high oral dose (-)-epigallocatechin-3-gallate in mice. Food Chem Toxicol. 2009; 48(1):409-16. PMC: 2905152. DOI: 10.1016/j.fct.2009.10.030. View

Saper R, Phillips R, Sehgal A, Khouri N, Davis R, Paquin J . Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA. 2008; 300(8):915-23. PMC: 2755247. DOI: 10.1001/jama.300.8.915. View

Fontana R, Watkins P, Bonkovsky H, Chalasani N, Davern T, Serrano J . Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009; 32(1):55-68. PMC: 3637941. DOI: 10.2165/00002018-200932010-00005. View

Zheng E, Navarro V . Liver Injury from Herbal, Dietary, and Weight Loss Supplements: a Review. J Clin Transl Hepatol. 2015; 3(2):93-8. PMC: 4548352. DOI: 10.14218/JCTH.2015.00006. View

Timbo B, Ross M, McCarthy P, Lin C . Dietary supplements in a national survey: Prevalence of use and reports of adverse events. J Am Diet Assoc. 2006; 106(12):1966-74. DOI: 10.1016/j.jada.2006.09.002. View

Benichou C, Danan G, Flahault A . Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiol. 1993; 46(11):1331-6. DOI: 10.1016/0895-4356(93)90102-7. View

Foley S, Butlin E, Shields W, Lacey B . Experience with OxyELITE pro and acute liver injury in active duty service members. Dig Dis Sci. 2014; 59(12):3117-21. DOI: 10.1007/s10620-014-3221-4. View

10.

Navarro V, Barnhart H, Bonkovsky H, Davern T, Fontana R, Grant L . Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014; 60(4):1399-408. PMC: 4293199. DOI: 10.1002/hep.27317. View

11.

Kapetanovic I, Crowell J, Krishnaraj R, Zakharov A, Lindeblad M, Lyubimov A . Exposure and toxicity of green tea polyphenols in fasted and non-fasted dogs. Toxicology. 2009; 260(1-3):28-36. PMC: 2687403. DOI: 10.1016/j.tox.2009.03.007. View

12.

. Notes from the field: acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building--May-October 2013. MMWR Morb Mortal Wkly Rep. 2013; 62(40):817-9. PMC: 4585555. View

13.

Gahche J, Bailey R, Burt V, Hughes J, Yetley E, Dwyer J . Dietary supplement use among U.S. adults has increased since NHANES III (1988-1994). NCHS Data Brief. 2011; (61):1-8. View

14.

I Johnston D, Chang A, Viray M, Chatham-Stephens K, He H, Taylor E . Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ - Hawaii, 2013. Drug Test Anal. 2015; 8(3-4):319-27. PMC: 4833726. DOI: 10.1002/dta.1894. View

15.

Suzuki A, Brunt E, Kleiner D, Miquel R, Smyrk T, Andrade R . The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury. Hepatology. 2011; 54(3):931-9. PMC: 3192933. DOI: 10.1002/hep.24481. View

16.

Fong T, Klontz K, Canas-Coto A, Casper S, Durazo F, Davern 2nd T . Hepatotoxicity due to hydroxycut: a case series. Am J Gastroenterol. 2010; 105(7):1561-6. PMC: 3825455. DOI: 10.1038/ajg.2010.5. View

17.

Bonkovsky H . Hepatotoxicity associated with supplements containing Chinese green tea (Camellia sinensis). Ann Intern Med. 2006; 144(1):68-71. DOI: 10.7326/0003-4819-144-1-200601030-00020. View

18.

Kleiner D, Chalasani N, Lee W, Fontana R, Bonkovsky H, Watkins P . Hepatic histological findings in suspected drug-induced liver injury: systematic evaluation and clinical associations. Hepatology. 2013; 59(2):661-70. PMC: 3946736. DOI: 10.1002/hep.26709. View

19.

Stravitz R, Lefkowitch J, Fontana R, Gershwin M, Leung P, Sterling R . Autoimmune acute liver failure: proposed clinical and histological criteria. Hepatology. 2011; 53(2):517-26. PMC: 3080034. DOI: 10.1002/hep.24080. View

20.

Fontana R, Hayashi P, Gu J, Reddy K, Barnhart H, Watkins P . Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset. Gastroenterology. 2014; 147(1):96-108.e4. PMC: 4285559. DOI: 10.1053/j.gastro.2014.03.045. View