United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Toxicology Reports

Cynthia V. Rider¹  Theertham P. Rao²  Kan He³  Robin J. Marles⁴  Tieraona Low Dog⁵  Joseph M. Betz⁶  Amy L. Roe⁷  Bill Gurley⁷  Gabriel I. Giancaspro⁸  Jose Serrano⁹  Richard Ko⁹  Mary F. Paine^1,10  Simona Rossi^1,10  Hellen A. Oketch-Rabah^1,11  Steven Casper^1,11  Leonard B. Seeff^1,12  Robert J. Fontana^1,12  Herbert L. Bonkovsky^1,12  Scott A. Jordan^1,12  Mahendra P. Kapoor^1,12  Averell H. Sherker^1,12  Christopher Koh^1,12  Andrew Stolz^1,12  Jawad Ahmad^1,12  Victor Navarro^1,12  Raj Vuppalanchi^1,12 

[1] Corresponding author at: 12601 Twinbrook Pkwy, Rockville, MD, 20852, USA.;Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, WA, USA;Expert Members of the Drug Induced Liver Injury Network (DILIN), USA;Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA;Liver Diseases Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD, USA;;Section on Gastroenterology &United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA;Vice Chair, (USP GTEH EP, 2015-2020 cycle), USA;Expert Members of the Drug Induced Liver Injury Network (DILIN), USA;U.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle), USA;U.S. Pharmacopeial Convention, Rockville, MD, USA;United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA;

关键词: Green tea;    Camellia sinensis;    Dietary supplements;    Hepatotoxicity;    Liver injury;    Green tea extract;   

DOI  :  

来源: DOAJ

【 摘 要 】

As part of the United States Pharmacopeia’s ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: “Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”

【 授权许可】

Unknown