Health Canada to strengthen warnings for green tea extracts

Health Canada to strengthen warnings for green tea extracts Reactions 1680, p1 - 2 Dec 2017 Health Canada to strengthen warnings for green tea extracts There is a need for stronger warnings about the rare, but potentially serious, risk of liver injury with natural health products containing green tea extract, says 1,2 Health Canada. "Green tea in any form, including as beverages, foods and an extract in natural health products, is considered generally safe for the majority of consumers", stated Health Canada. There are a number of green tea extract-containing herbal products that are used for a variety of conditions, including weight management and as a source of antioxidants. Health Canada recently completed a safety review of such green tea extract-containing health products, following continued worldwide reports of serious liver injury (including a recent Canadian report). The risk of liver-related injury is already included in the approved Canadian labelling (or product monographs) for such products. However, Health Canada’s recent review "concluded that the available evidence confirms a link between green tea extract and rare liver-related adverse reactions", noted the agency. Health Canada has reiterated these safety concerns in a "Dear Healthcare Professional" letter. The agency’s product monograph relating to "Green Tea Extracts" will be updated to include the following strengthened warning statements: "If you have a liver disorder, consult a health care practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a health care practitioner", and; "Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally)". In addition, Health Canada has requested marketing authorisation holders of natural health products containing green tea extract as a medicinal ingredient and that are intended for use in children or adolescents either: (i) remove the green tea extract from the product, or (ii) revise the product labelling to indicate that it should only be used in adults (i.e. ≥18 years). * available in capsule, tablet, powder and liquid formulations. 1. Health Canada. Health Canada takes steps to help Canadians avoid rare risk of liver injury from use of green tea extract health products. Internet Document : 14 Nov 2017. Available from: URL: http://healthycanadians.gc.ca/recall-alert- rappel-avis/hc-sc/2017/65114a-eng.php. 2. Health Canada. Green Tea Extract-Containing Natural Health Products - Rare Risk of Serious Liver Injury. Internet Document : 15 Nov 2017. Available from: URL: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/65100a- eng.php. 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Health Canada to strengthen warnings for green tea extracts

Reactions Weekly , Volume 1680 (1) – Dec 2, 2017
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Publisher
Springer Journals
Copyright
Copyright © 2017 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-38932-6
Publisher site
See Article on Publisher Site

Abstract

Reactions 1680, p1 - 2 Dec 2017 Health Canada to strengthen warnings for green tea extracts There is a need for stronger warnings about the rare, but potentially serious, risk of liver injury with natural health products containing green tea extract, says 1,2 Health Canada. "Green tea in any form, including as beverages, foods and an extract in natural health products, is considered generally safe for the majority of consumers", stated Health Canada. There are a number of green tea extract-containing herbal products that are used for a variety of conditions, including weight management and as a source of antioxidants. Health Canada recently completed a safety review of such green tea extract-containing health products, following continued worldwide reports of serious liver injury (including a recent Canadian report). The risk of liver-related injury is already included in the approved Canadian labelling (or product monographs) for such products. However, Health Canada’s recent review "concluded that the available evidence confirms a link between green tea extract and rare liver-related adverse reactions", noted the agency. Health Canada has reiterated these safety concerns in a "Dear Healthcare Professional" letter. The agency’s product monograph relating to "Green Tea Extracts" will be updated to include the following strengthened warning statements: "If you have a liver disorder, consult a health care practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a health care practitioner", and; "Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally)". In addition, Health Canada has requested marketing authorisation holders of natural health products containing green tea extract as a medicinal ingredient and that are intended for use in children or adolescents either: (i) remove the green tea extract from the product, or (ii) revise the product labelling to indicate that it should only be used in adults (i.e. ≥18 years). * available in capsule, tablet, powder and liquid formulations. 1. Health Canada. Health Canada takes steps to help Canadians avoid rare risk of liver injury from use of green tea extract health products. Internet Document : 14 Nov 2017. Available from: URL: http://healthycanadians.gc.ca/recall-alert- rappel-avis/hc-sc/2017/65114a-eng.php. 2. Health Canada. Green Tea Extract-Containing Natural Health Products - Rare Risk of Serious Liver Injury. Internet Document : 15 Nov 2017. Available from: URL: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/65100a- eng.php. 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680

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Reactions WeeklySpringer Journals

Published: Dec 2, 2017

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