Aristolochia fact sheet
24 May 2001
- All species of Aristolochia are prohibited for supply, sale or use in therapeutic goods in Australia. However, Aristolochia species appear to be finding their way into some herbal-based Traditional Chinese Medicine products because they may be confused with other herbs of similar appearance or similar name.
- Herbal species most vulnerable to substitution by Aristolochia include some species of the following herbs: Akebia, Asarum, Bragantia, Clematis, Cocculus, Diploclisia, Menispernum, Saussurea, Sinomenium, Stephania, Vladimiria. Traditional Chinese medicine herbal products containing Mu Tong and Fang Ji as ingredients may also be at risk of containing the Aristolochia species.
- Aristolochia species and its particular components known as 'aristolochic acids' have been linked to severe kidney damage and urinary tract cancer and there have been reports in a number of overseas countries of serious reactions to herbal products containing Aristolochia. This has usually occurred when an Aritolochia herb was mistakenly compounded into a preparation for a particular medicinal use instead of another herb.
- The TGA is not aware of any adverse reaction reports of kidney damage or urinary tract cancer associated with the inadvertent use of herbal products containing Aristolochia species in Australia. But the TGA has worked closely with overseas regulatory agencies (including those in the UK and the USA) to identify species and herbal products likely to contain aristolochic acids.
- The TGA has previously issued a detailed alert to health practitioners, warning them of the possible confusion of Aristolochia with other herbs used in Traditional Chinese Medicines. This practitioner alert contains important information and is contained on this website.
- The TGA has tested all products on the Australian Register of Therapeutic Goods currently available in Australia where Aristolochia species may possibly have been substituted for other herbs.
- Ongoing surveillance by TGA has found that a small number of these products contain aristolochic acids and permission to continue to trade in these has been cancelled. The Australian based sponsor of these products has been required to recall all current stocks. The products in question are Chaun Xiong Cha Tiao San (AUSTL 42653), Xiao Feng San (AUSTL 11725) and Ba Zheng San (AUSTL 11655) and are made by Cathay Wholesale Pty Ltd.
- All manufacturers are required to put in place measures to ensure that future batches of products containing the herbs most likely to be substituted for Aristolochia are free from the Aristolochia species or from the aristolochic acids.
- Healthcare practitioners are asked to take extreme caution in using herbal products, in raw or formulated form, if they contain any of the herbs listed above. If healthcare practitioners are uncertain about the identity and authenticity of any of the herbal materials or products named above, they should consider discontinuing their use.
- Consumers who may have taken these medicines recently are being contacted by the prescribing healthcare practitioner. However, if in doubt, consumers should contact their practitioner as soon as possible to have their medications reviewed.