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. 2018 Dec;8(4):471-473.
doi: 10.1016/j.jceh.2018.05.001. Epub 2018 May 17.

Chemical Analysis of Weight Loss Herbal Supplement Safe Lean™ Associated With Acute Liver Injury - A Concern for Spurious Drug, Misbranding and Adulteration

Cyriac A Philips  1 , Philip Augustine  1
Affiliations

Chemical Analysis of Weight Loss Herbal Supplement Safe Lean™ Associated With Acute Liver Injury - A Concern for Spurious Drug, Misbranding and Adulteration

Cyriac A Philips et al. J Clin Exp Hepatol. 2018 Dec.

Abstract

Liver injury due to herbal and dietary supplements are well described in literature and its incidence has been on the rise in the past decade. Labelling an herbal product as non-medicinal and as a supplement precludes protocols needed for testing, trials and marketing criteria. This has led to rampant use of clinically unproven multi-herb-based drugs use for a myriad of lifestyle diseases. In this report, we discuss a new dietary weight loss supplement, Safe Lean™ that was found to be the cause of liver injury in a young obese woman, that resolved after discontinuation, and discuss current literature on component, toxicology and chemical analysis of the offending drug.

Keywords: CAM; DILI; DMAA, Dimethylamylamine; DNA, Deoxyribonucleic Acid; GMP, Good Manufacturing Practices; HDS, Herbal Dietary Supplements; ICP-OES, Inductively Coupled Plasma – Optical Emission Spectrometry; RUCAM, Roussel Uclaf Causality Assessment Method; TQ-GC-MS-MS, Triple Quadruple Gas Chromatography and Dual Mass Spectroscopy; ULN, Upper Limit of Normal; WHO, World Health Organization; ayurveda; herbal; liver injury.

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Figures

Figure 1
Figure 1
Retrieved samples of Safe Lean™ dietary and herbal supplement that caused acute hepatitis in the patient.
See this image and copyright information in PMC

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