Author(s)

Vasilios Frankos¹, Raushanah Najeeullah², Joel Morgan³

¹Global Regulatory Compliance and Product Safety, Herbalife International of America Inc., Torrance, CA, USA.
²Post Market Medical Surveillance, Global Post-Market Safety Surveillance, Herbalife International of America Inc., Torrance, CA, USA.
³Global Post-Market Safety Surveillance, Herbalife International of America Inc., Torrance, CA, USA.

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.

Drug-Induced Liver Injury, RUCAM, Herb-Induced Liver Injury, Causality, Dietary Supplement

Frankos, V. , Najeeullah, R. and Morgan, J. (2016) Critical Evaluation for Alternative Causes of Drug Induced and Herbal Induced (DILI/HILI) Hepatotoxicity. Health, 8, 800-804. doi: 10.4236/health.2016.89084.