United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.
ADME, Absorption, distribution, metabolism, and excretion
ALP, alkaline phosphatase
ALT, alanine aminotransferase
AST, aspartate aminotransferase
AUC, area under the curve
Bw, body weight
C, Catechin
CAM, causality assessment method
CG, (+)‐catechin‐3‐gallate
CIH, Concanavalin A-induced hepatitis
CMC, chemistry, manufacturing, and controls
COMT, catechol‐O‐methyltransferase
Camellia sinensis
ConA, Concanavalin A
DILI, drug‐induced liver injury
DILIN, Drug‐Induced Liver Injury Network
DO, Diversity Outbred
DS, Dietary Supplement
DSAE, JS3 USP Dietary Supplements Admission Evaluations Joint Standard-Setting Subcommittee
Dietary supplements
EC, (–)‐epicatechin
ECG, (‐)‐epicatechin‐3‐gallate
EFSA, European Food Safety Authority
EGC, (–)‐epigallocatechin
EGCG, (–)‐epigallocatechin‐3‐gallate
FDA, United States Food and Drug Administration
GC, (+)‐gallocatechin
GCG, (–)‐gallocatechin‐3‐gallate
GT(E), green tea or green tea extract
GT, green tea
GTE, green tea extract
GTEH, EP Green Tea Extract Hepatotoxicity Expert Panel
Green tea
Green tea extract
HDS, herbal dietary supplement
HPMC, Hydroxypropyl methylcellulose
Hepatotoxicity
LD50, lethal dose, median
LFT(s), liver function test(s)
LT(s), Liver test(s)
Liver injury
MGTT, Minnesota Green Tea Trial
MIDS, multi-ingredient dietary supplement
MRL, maximum residue limit
NAA, N-acetyl aspartate
NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases
NIH, National Institutes of Health
NOAEL, no observed adverse effect level
NTP, National Toxicology Program
OSM, online supplementary material
PAs, Pyrrolizidine Alkaloids
PD-1, Programmed death domain-1
PDGTE, powdered decaffeinated green tea extract
PK/PD, pharmacokinetics and pharmacodynamics
RUCAM, Roussel Uclaf Causality Assessment Method
SIDS, single-ingredient dietary supplement
TGF-beta, Transforming growth factor beta
USP, United States Pharmacopeia
γ-GT, Gamma-glutamyl transferase
Journal
Toxicology reports
ISSN: 2214-7500
Titre abrégé: Toxicol Rep
Pays: Ireland
ID NLM: 101630272
Informations de publication
Date de publication:
2020
2020
Historique:
received:
22
12
2019
revised:
04
02
2020
accepted:
12
02
2020
entrez:
7
3
2020
pubmed:
7
3
2020
medline:
7
3
2020
Statut:
epublish
Résumé
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: "
Identifiants
pubmed: 32140423
doi: 10.1016/j.toxrep.2020.02.008
pii: S2214-7500(19)30659-6
pmc: PMC7044683
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
386-402Informations de copyright
© 2020 Published by Elsevier B.V.
Déclaration de conflit d'intérêts
The authors have declared the following: HAO-R and GIG are employed by USP. The below listed authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper: Hellen A Oketch-Rabah, Gabriel I. Giancaspro, Jawad Ahmad, Steven Casper, Bill Gurley, Cynthia V. Rider, Leonard B Seef, Jose Serrano, Joseph M. Betz, Christopher Koh, Kan He, Mary F. Paine, Raj Vuppalanchi, Robin J. Marles, Averell H. Sherker, Simona Rossi, Scott Jordan, Victor J. Navarro, Andrew Stolz. The below listed authors declare the described financial interests/personal relationships which may be considered as potential competing interests: Tieraona Low Dog is a Consultant at MegaFoods; Herbert L. Bonkovsky has been and continues to be an investigator in the NIH-sponsored US Drug-Induced Liver Injury Network since 2003 and is supported by a cooperative agreement between NIDDK and UNC & Wake Forest University, U01 DK 065201; Amy L. Roe works for a company that manufactures and distributes dietary supplements; including some that may contain green tea extract; Richard Ko is the founder and owner of Herbal Synergy, a company that consults for the dietary supplement, food, and pharmaceutical companies; Kan He is employed by Herbalife, a company that manufactures and distributes dietary supplement that may contain green tea or green tea extracts; Robert J. Fontana receives research support from Gilead, Abbvie, and BristolMyerSquibb, and also provides consulting for Alynam and AstraZeneca; Mahendra P. Kapoor is an employee of Taiyo Kagaku Co Ltd, a company that manufactures several nutraceutical ingredients including green tea extracts; Theertham Pradyumna Rao is an employee of Taiyo Kagaku Co Ltd, a company that manufactures several nutraceutical ingredients including green tea extracts.
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