United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts
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...
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Elsevier
2020-01-01
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Series: | Toxicology Reports |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S2214750019306596 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hellen A. Oketch-Rabah Amy L. Roe Cynthia V. Rider Herbert L. Bonkovsky Gabriel I. Giancaspro Victor Navarro Mary F. Paine Joseph M. Betz Robin J. Marles Steven Casper Bill Gurley Scott A. Jordan Kan He Mahendra P. Kapoor Theertham P. Rao Averell H. Sherker Robert J. Fontana Simona Rossi Raj Vuppalanchi Leonard B. Seeff Andrew Stolz Jawad Ahmad Christopher Koh Jose Serrano Tieraona Low Dog Richard Ko |
spellingShingle |
Hellen A. Oketch-Rabah Amy L. Roe Cynthia V. Rider Herbert L. Bonkovsky Gabriel I. Giancaspro Victor Navarro Mary F. Paine Joseph M. Betz Robin J. Marles Steven Casper Bill Gurley Scott A. Jordan Kan He Mahendra P. Kapoor Theertham P. Rao Averell H. Sherker Robert J. Fontana Simona Rossi Raj Vuppalanchi Leonard B. Seeff Andrew Stolz Jawad Ahmad Christopher Koh Jose Serrano Tieraona Low Dog Richard Ko United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts Toxicology Reports Green tea Camellia sinensis Dietary supplements Hepatotoxicity Liver injury Green tea extract |
author_facet |
Hellen A. Oketch-Rabah Amy L. Roe Cynthia V. Rider Herbert L. Bonkovsky Gabriel I. Giancaspro Victor Navarro Mary F. Paine Joseph M. Betz Robin J. Marles Steven Casper Bill Gurley Scott A. Jordan Kan He Mahendra P. Kapoor Theertham P. Rao Averell H. Sherker Robert J. Fontana Simona Rossi Raj Vuppalanchi Leonard B. Seeff Andrew Stolz Jawad Ahmad Christopher Koh Jose Serrano Tieraona Low Dog Richard Ko |
author_sort |
Hellen A. Oketch-Rabah |
title |
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts |
title_short |
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts |
title_full |
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts |
title_fullStr |
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts |
title_full_unstemmed |
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts |
title_sort |
united states pharmacopeia (usp) comprehensive review of the hepatotoxicity of green tea extracts |
publisher |
Elsevier |
series |
Toxicology Reports |
issn |
2214-7500 |
publishDate |
2020-01-01 |
description |
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).” |
topic |
Green tea Camellia sinensis Dietary supplements Hepatotoxicity Liver injury Green tea extract |
url |
http://www.sciencedirect.com/science/article/pii/S2214750019306596 |
work_keys_str_mv |
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doaj-d2d9065cabf74b6d8673dea045edc21e2020-12-25T05:10:01ZengElsevierToxicology Reports2214-75002020-01-017386402United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extractsHellen A. Oketch-Rabah0Amy L. Roe1Cynthia V. Rider2Herbert L. Bonkovsky3Gabriel I. Giancaspro4Victor Navarro5Mary F. Paine6Joseph M. Betz7Robin J. Marles8Steven Casper9Bill Gurley10Scott A. Jordan11Kan He12Mahendra P. Kapoor13Theertham P. Rao14Averell H. Sherker15Robert J. Fontana16Simona Rossi17Raj Vuppalanchi18Leonard B. Seeff19Andrew Stolz20Jawad Ahmad21Christopher Koh22Jose Serrano23Tieraona Low Dog24Richard Ko25U.S. Pharmacopeial Convention, Rockville, MD, USA; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA; Corresponding author at: 12601 Twinbrook Pkwy, Rockville, MD, 20852, USA.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), USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAU.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle), USA; Section on Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USAU.S. Pharmacopeial Convention, Rockville, MD, USA; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA; Expert Members of the Drug Induced Liver Injury Network (DILIN), USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA; Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, WA, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAU.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle), USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USA; Liver Diseases Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD, USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USA; Department of Internal Medicine, University of Michigan, Ann Arbor, MI, 48109, USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USAU.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle), USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USA; Liver Diseases Branch, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, 10 Center Drive, Building 10, Rm 9B-16, Bethesda, MD, 20892, USAExpert Members of the Drug Induced Liver Injury Network (DILIN), USA; Liver Diseases Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USAUnited States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA; Chair (USP GTEH EP, 2015-2020 cycle), USAAs 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).”http://www.sciencedirect.com/science/article/pii/S2214750019306596Green teaCamellia sinensisDietary supplementsHepatotoxicityLiver injuryGreen tea extract |