Title

Safety of green tea extracts : a systematic review by the US Pharmacopeia

UMMS Affiliation

Center for Integrated Primary Care; Department of Family Medicine and Community Health

Publication Date

6-1-2008

Document Type

Article

Disciplines

Alternative and Complementary Medicine | Dietetics and Clinical Nutrition | Integrative Medicine | Pharmacy Administration, Policy and Regulation | Primary Care

Abstract

Green tea [Camellia sinensis (L.) Kuntze] is the fourth most commonly used dietary supplement in the US. Recently, regulatory agencies in France and Spain suspended market authorization of a weight-loss product containing green tea extract because of hepatotoxicity concerns. This was followed by publication of adverse event case reports involving green tea products. In response, the US Pharmacopeia (USP) Dietary Supplement Information Expert Committee (DSI EC) systematically reviewed the safety information for green tea products in order to re-evaluate the current safety class to which these products are assigned. DSI EC searched PubMed (January 1966-June 2007) and EMBASE (January 1988-June 2007) for clinical case reports and animal pharmacological or toxicological information. Reports were also obtained from a diverse range of other sources, including published reviews, the US FDA MedWatch programme, USP's MEDMARX adverse event reporting system, the Australian Therapeutic Goods Administration, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada's Canadian Adverse Drug Reaction Monitoring Program. Case reports pertaining to liver damage were evaluated according to the Naranjo causality algorithm scale. In addition, the Committee analysed information concerning historical use, regulatory status, and current extent of use of green tea products. A total of 216 case reports on green tea products were analysed, including 34 reports concerning liver damage. Twenty-seven reports pertaining to liver damage were categorized as possible causality and seven as probable causality. Clinical pharmacokinetic and animal toxicological information indicated that consumption of green tea concentrated extracts on an empty stomach is more likely to lead to adverse effects than consumption in the fed state. Based on this safety review, the DSI EC determined that when dietary supplement products containing green tea extracts are used and formulated appropriately the Committee is unaware of significant safety issues that would prohibit monograph development, provided a caution statement is included in the labelling section. Following this decision, USP's DSI ECs may develop monographs for green tea extracts, and USP may offer its verification programmes related to that dietary ingredient.

Keywords

EGCG, Adverse Event Report, Probable Causality, Causality Rating, Polyherbal Formulation

DOI of Published Version

10.2165/00002018-200831060-00003

Source

Drug Saf. 2008;31(6):469-84. doi: 10.2165/00002018-200831060-00003. Link to article on publisher's site

Journal/Book/Conference Title

Drug safety

Comments

At the time of publication, Paula Gardiner was not yet affiliated with the University of Massachusetts Medical School.

Related Resources

Link to Article in PubMed

PubMed ID

18484782

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