Australia : Camellia sinensis (green tea) extract - Safety advisory - potential risk of harm to the liver (English Only)
 
Therapeutic Goods Administration (TGA) announces that rare cases of harm to the liver have been associated with products that contain Camellia sinensis (green tea) extracts. 

Camellia sinensis (C. sinensis) is a herbal ingredient permitted for use in low-risk medicines in Australia. Approximately 267 listed medicines in the Australian Register of Therapeutic Goods (ARTG) contain C. sinensis; the majority of which contain the ingredient as a concentrated extract. These products are often used to assist with weight management and as source of antioxidants. 

Medicines containing C. sinensis extracts have been associated with a number of cases of liver toxicity world-wide, although the incidence appears to be rare and unpredictable. The majority of C. sinensis use (including green tea in beverage form) is unlikely to cause harm, therefore the TGA considers that a recall of C. sinensis products is not warranted. 

The underlying reasons why liver injury has occurred are not well understood at this stage. Twenty adverse events have been reported to the TGA associated with both C. sinensis-containing products and liver injury. All but one of these events involved products containing concentrated extracts of the ingredient. Most cases (17) involved multiple suspected products and/or multi-ingredient products. In three cases, the sole suspected product contained C. sinensis as the only active ingredient. 

Canada’s therapeutic goods regulator, Health Canada, and the European Food Safety Authority have also published information on the risk of harm to the liver by C. sinensis extracts. 

The TGA is continuing to monitor the safety of C. sinensis and encourages consumers and health professionals to report any suspected problems associated with a product containing C. sinensis, especially any cases relating to the liver, to the TGA. 

Please refer to the following website in TGA for details: http://www.tga.gov.au/alert/camellia-sinensis-green-tea-extract 

In Hong Kong, there is no registered pharmaceutical product containing Camellia sinensis (green tea) extracts. 

Ends/ Wednesday, June 6, 2018 
Issued at HKT 17:45 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/