Abstract

The objective of this review is to highlight the continued exclusion of discussion in the literature regarding alternative causes and proper causality assessment of cases of hepatotoxicity when use of dietary supplements is reported. Though independent experts are working diligently to advance the discussion related to alternative causes of hepatotoxicity resulting in idiosyncratic drug-induced liver injury/herb-induced liver injury (DILI/HILI), the literature continues to recite the same cases, such as those presented here, to reiterate potentially biased positions and ignore current, standardized and valid evaluations utilizing the Roussel Uclaf Causality Assessment Method (RUCAM). Several historical cases purporting hepatotoxicity induced by use of dietary supplements are presented in this review to demonstrate how such cases may be improperly assessed due to bias, inconsistent use of causality assessment methods, as well as use of causality assessment methods deemed obsolete. This in essence, delays any true progress in establishing sound criteria to determine and address the actual cause(s) of DILI/HILI.

Highlights

  • Dietary supplements (DS) are an ever growing sector of healthcare, along with lifestyle and wellness trends, How to cite this paper: Frankos, V., Najeeullah, R. and Morgan, J. (2016) Critical Evaluation for Alternative Causes of Drug Induced and Herbal Induced (DILI/HILI) Hepatotoxicity

  • There is a growing trend to reevaluate these reported cases for alternative causes using the more consistent and objective Roussel Uclaf Causality Assessment Method (RUCAM) causality assessment method in order to determine the actual causative risk factor(s) for the development of DILI/HILI [1]-[4] though it continues to be largely ignored in the literature

  • While weight loss can be a necessary component for disease management [5]-[7], there are health risks associated with any weight loss regimen including lipotoxicity or gall stone formation from rapid weight loss [8]-[10] which can lead to a case of liver injury being diagnosed as DILI/HILI where DS consumption was reported

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Summary

Introduction

Dietary supplements (DS) are an ever growing sector of healthcare, along with lifestyle and wellness trends, How to cite this paper: Frankos, V., Najeeullah, R. and Morgan, J. (2016) Critical Evaluation for Alternative Causes of Drug Induced and Herbal Induced (DILI/HILI) Hepatotoxicity. Some of the current issues plaguing meaningful discussion around DILI/HILI and the use of DS include: lack of discussion of alternative causes of hepatotoxicity including liver injury linked to rapid weight loss; preexisting health conditions such as obesity, insulin resistance, diabetes, hepatic steatosis and non-alcoholic fatty liver disease (NAFLD) [14]-[19] (see Table 1); disregard of the reassessment of retrospective cases originally concluded to have been caused by consumption of DS but later determined, by independent experts, to have likely been caused by other preexisting medical conditions, use of known hepatotoxic medications, and other factors; and the implication of a DS brand name as if it constituted a single drug, supplement or herb instead of identifying a single DS product or ingredient sold under a particular brand name.

DS causality determined on reevaluation
Conclusion
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