In June 2001, the FDA issued a nation-wide alert recalling 13 ‘Treasure of the East’ herbal products containing aristolochic acid (1). Aristolochic acid, found in certain plants and botanicals is a potent carcinogen and can cause serious kidney damage. A complete list of the recalled products may be found on the FDA website, under FDA News (http://www.fda.gov).
Earlier to this alert, the FDA had issued several warnings:
1. On 4 April 2001 a ‘Dear Health Professional’ letter was sent drawing attention to serious renal disease associated with the use of aristolochic acid-containing dietary supplements or ‘traditional medicines’(2). Health professionals were urged to review patients who had experienced unexplained renal disease, especially those with urothelial tract tumours and interstitial nephritis with end-stage renal failure, to determine if such products had been used.
2. On 9 April 2001 a letter to industry associations was sent, which details the reported cases of renal disease associated with aristolochic acid(3).
3. On 11 April 2001 the FDA cautioned consumers to immediately discontinue use of any dietary supplements o r ‘traditional medicine’ that contain aristolochic acid, including products with ‘Aristolochia’, ‘Bragantia’ or ‘Asarum’ listed as their ingredients(4).
In a related action, Health Canada has warned consumers not to use the paediatric product Tao Chih Pien(5). This Chinese product, which is sold in the form of tablets, is said to be a diuretic and a laxative. It is not labelled to contain aristolochic acid.
However the Chinese labelling says that it contains Mu Tong, a traditional term used to describe numerous herbs, including aristolochia. Subsequent product analysis has found that Tao Chih Pien does indeed contain aristolochic acid. Health Canada has now advised individuals in possession of this product not to consume it and to return it to the place of purchase. It has also issued a Customs Alert for the product to prevent the importation and sale of Tao Chih Pien.
Reports in WHO-file: Renal function abnormal 1
1. FDA News, 20 Jun 2001. Available from URL: http://www.fda.gov
2. Media Release, 4 Apr 2001. Available from URL: http://www.cfsan.fda.gov
3. Media Release, 9 Apr 2001. Available from URL: http://www.cfsan.fda.gov
4. Media Release, 11 Apr 2001. Available from URL: http://www.cfsan.fda.gov
5. Health Canada Advisories/Warnings, 24 Aug 2001. Available from URL: http://www.hc-sc.gc.ca