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

Abstract

BACKGROUND/AIMS Herbal and dietary supplement (HDS) hepatotoxicity is increasingly being reported in the United States. This case series describes the presenting clinical features and outcomes of 7 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 7 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 to 102 weeks). Median age was 36 years (range: 28 to 62), 86% were female, and 43% were Asian. One patient had rash, none had eosinophilia and 3 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, 3 developed acute liver failure and 2 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 5 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.

Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

“…Also, it appears that only part of the requested alternative virus infections such as HSV and VZV was excluded, which creates problems as any diagnosis of organ injury is a diagnosis of exclusion, not fulfilled in this report [281]. Even more problematic was the approach to exclude HEV, as assessment was confounded by positive anti-HEV IgG titers, incomplete analysis of essential HEV parameters, and not prospective evaluations.…”

“…RUCAM is rarely used in the United States (Table 11 and Table 12), where the DILIN method is preferred, which circumvents scoring of individual items and obviates transparency (Table 10) [51] as shown also in a recent report of seven cases with suspected liver injury [281]. In this study, RUCAM causality levels were low with unlikely in one case, possible in four cases, and probable in two cases only; conversely, the DILIN method attributed a probable or higher causality to six cases and a possible causality to one case.…”

“…Case evaluations were confounded by an undefined reexposure test, several comedications, as 5/7 patients (71.4%) used up to two other prescription medications or herbal dietary supplements, and preexisting chronic HBV infection, which caused liver cirrhosis, requiring a liver transplant. The suggestion that DILI may have superimposed on chronic HBV infection [281] appears unlikely in view of clinical experience and a previous analysis [198]. …”

“…Even more problematic was the approach to exclude HEV, as assessment was confounded by positive anti-HEV IgG titers, incomplete analysis of essential HEV parameters, and not prospective evaluations. HEV-RNA was not at all determined in any of the cases for unknown reasons, and the used HEV antibody assays were not specified [281], disregarding the well-known problem of lacking FDA approval [241,242,282]. For none of these seven patients, product use or purchase was confirmed, nor was a product analysis done.…”

Non-evidence-Based Medicine: The Gastroenterologist’s Role and Responsibility

“…In contrast to medications that undergo testing in multiple phases for safety and efficacy prior to their being made available to the public, supplements on this parallel track are presumed safe on introduction to the market, and the FDA initiates an investigation only if reports suggestive of a hazard are submitted. For example, the hepatotoxic effects of the nutritional supplement OxyELITE Pro were discovered not in a clinical trial but after more than 40 patients developed severe acute hepatitis, requiring liver transplantation in some cases [2].…”