Camellia sinensis (green tea) extract

Consumers and health professionals are advised 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.

Information for consumers

If you or someone you provide care for has been taking a product containing C. sinensis (green tea) please be aware of this issue. Products that contain C. sinensis that are included in the ARTG will include the ingredient Camellia sinensis on the label.

If you develop any of the following problems, stop taking a product containing C.sinensis and contact your doctor as soon as possible:

• nausea
• stomach pain
• pale stools
• dark urine
• itching all-over
• the whites of the eyes have turned yellow or the skin is yellow (jaundice).

If you have any questions or concerns about this issue, contact your health professional.

If you suspect you have had a side effect to a product containing C.sinensis, please report it to the TGA.

Information for health professionals

If you are treating a patient who is using or has recently used a product containing C.sinensis, please be aware of this issue.

Patients who develop signs of liver problems should be advised to cease the product immediately and be followed up appropriately.

Please report any suspected problems associated with products that contain C. sinensis, especially any cases related to the liver, to the TGA. This will assist the TGA to continue to monitor the safety of this ingredient.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.