Observational studyDigestive diseases and sciences2016
Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series.
Observational study in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Complementary and Alternative Therapies for Weight Loss: A Narrative Review.Journal of evidence-based integrative medicinePooled it
- Notifications and Health Consequences of Unauthorized Pharmaceuticals in Food Supplements.Pharmacy (Basel, Switzerland) · 2023Article
- Hepatotoxicity due to herbal dietary supplements: Past, present and the future.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2022Review
- Secular Trends in Severe Idiosyncratic Drug-Induced Liver Injury in North America: An Update From the Acute Liver Failure Study Group Registry.The American journal of gastroenterology · 2022Article
- Signatures in drug-induced liver injury.Current opinion in gastroenterology · 2020Review
- Severe liver injury due to herbal and dietary supplements and the role of liver transplantation.World journal of gastroenterology · 2019Review
- Severe Acute Hepatitis Attributed to the Herbal and Dietary Supplement OxyELITE Pro.Clinical liver disease · 2019Review
- Impact of obesity on the toxicity of a multi-ingredient dietary supplement, OxyELITE Pro™ (New Formula), using the novel NZO/HILtJ obese mouse model: Physiological and mechanistic assessments.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2018Article
- Recent Advances in the Histopathology of Drug-Induced Liver Injury.Surgical pathology clinics · 2018Review
- Heavy Consumption of Alcohol is Not Associated With Worse Outcomes in Patients With Idiosyncratic Drug-induced Liver Injury Compared to Non-Drinkers.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018Article
- Non-evidence-Based Medicine: The Gastroenterologist's Role and Responsibility.Digestive diseases and sciences · 2018Article
- Adverse Effects of Nutraceuticals and Dietary Supplements.Annual review of pharmacology and toxicology · 2018Review
- Acute liver failure induced by idiosyncratic reaction to drugs: Challenges in diagnosis and therapy.Liver international : official journal of the International Association for the Study of the Liver · 2018Review
- Safety assessment of the dietary supplement OxyELITE™ Pro (New Formula) in inbred and outbred mouse strains.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2017Article
- Suspected Liver Injury and the Dilemma of Causality.Digestive diseases and sciences · 2017Article
- Liver injury from herbal and dietary supplements.Hepatology (Baltimore, Md.) · 2017Review
- Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs.Medicines (Basel, Switzerland) · 2016Review
Corrections and comments
- Erratum issued
Authors and funding
7 authors.
Funding
Abstract
BACKGROUND/
aimHerbal 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.
methodsThe 6-month outcomes of patients with hepatotoxicity attributed to OxyELITE Pro enrolled in the DILIN prospective registry between 2004 and 2015 are presented.
resultsSix 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.
conclusionsSeven 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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