title: Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series.
abstract: 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.
  
  
  
  The 6-month outcomes of patients with hepatotoxicity attributed to OxyELITE Pro enrolled in the DILIN prospective registry between 2004 and 2015 are presented.
  
  
  
  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.
  
  
  
  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.affiliation: Department of Internal Medicine, University of Michigan Medical Center, 3912 Taubman Center, Ann Arbor, MI, 48109-0362, USA.
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Heidemann
authors.affiliation: Department of Medicine, Einstein Healthcare Network, Philadelphia, PA, USA.
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Navarro
authors.affiliation: Department of Medicine, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY, USA.
authors.forename: Jawad
authors.initials: J
authors.lastname: Ahmad
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Paul H
authors.initials: PH
authors.lastname: Hayashi
authors.affiliation: University of Southern California, Los Angeles, CA, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Stolz
authors.affiliation: Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Kleiner
authors.affiliation: Department of Internal Medicine, University of Michigan Medical Center, 3912 Taubman Center, Ann Arbor, MI, 48109-0362, USA. rfontana@med.umich.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fontana
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D000577:Amides / Q000009:adverse effects*; D000974:Antibodies, Antinuclear / Q000276:immunology; D001663:Bilirubin / Q000097:blood; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000209:etiology* / Q000276:immunology / Q000628:therapy; D019587:Dietary Supplements / Q000009:adverse effects*; D005260:Female; D006801:Humans; D017114:Liver Failure, Acute / Q000139:chemically induced* / Q000601:surgery; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D028321:Plant Preparations / Q000009:adverse effects*; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D014481:United States
chemical_list: D000577:Amides; D000974:Antibodies, Antinuclear; D028321:Plant Preparations; C560978:aegeline; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin
keywords: Drug-induced liver injury; Hepatotoxicity; Herbal and dietary supplement