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Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series.
Dig Dis Sci 2016; 61(9):2741-8DD

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.

Authors+Show Affiliations

Department of Internal Medicine, University of Michigan Medical Center, 3912 Taubman Center, Ann Arbor, MI, 48109-0362, USA.Department of Medicine, Einstein Healthcare Network, Philadelphia, PA, USA.Department of Medicine, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY, USA.University of North Carolina, Chapel Hill, NC, USA.University of Southern California, Los Angeles, CA, USA.Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.Department of Internal Medicine, University of Michigan Medical Center, 3912 Taubman Center, Ann Arbor, MI, 48109-0362, USA. rfontana@med.umich.edu.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

27142670

Citation

Heidemann, Lauren A., et al. "Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: a Case Series." Digestive Diseases and Sciences, vol. 61, no. 9, 2016, pp. 2741-8.
Heidemann LA, Navarro VJ, Ahmad J, et al. Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series. Dig Dis Sci. 2016;61(9):2741-8.
Heidemann, L. A., Navarro, V. J., Ahmad, J., Hayashi, P. H., Stolz, A., Kleiner, D. E., & Fontana, R. J. (2016). Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series. Digestive Diseases and Sciences, 61(9), pp. 2741-8. doi:10.1007/s10620-016-4181-7.
Heidemann LA, et al. Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: a Case Series. Dig Dis Sci. 2016;61(9):2741-8. PubMed PMID: 27142670.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series. AU - Heidemann,Lauren A, AU - Navarro,Victor J, AU - Ahmad,Jawad, AU - Hayashi,Paul H, AU - Stolz,Andrew, AU - Kleiner,David E, AU - Fontana,Robert J, Y1 - 2016/05/03/ PY - 2016/03/09/received PY - 2016/04/20/accepted PY - 2016/5/5/entrez PY - 2016/5/5/pubmed PY - 2017/7/19/medline KW - Drug-induced liver injury KW - Hepatotoxicity KW - Herbal and dietary supplement SP - 2741 EP - 8 JF - Digestive diseases and sciences JO - Dig. Dis. Sci. VL - 61 IS - 9 N2 - 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. SN - 1573-2568 UR - https://www.unboundmedicine.com/medline/citation/27142670/Severe_Acute_Hepatocellular_Injury_Attributed_to_OxyELITE_Pro:_A_Case_Series_ L2 - https://doi.org/10.1007/s10620-016-4181-7 DB - PRIME DP - Unbound Medicine ER -