Health Canada

 Health Canada,   Sep 17, 2001

2001-100
September 17, 2001

Warning
Health Canada market survey confirms some products contain Aristolochic Acid

OTTAWA - Health Canada has completed its analysis of 48 traditional Chinese medicines labelled to contain Aristolochia, Akebia, Asarum, Clematis, Stephania, Caulus Hocquaria Manshuriensis or MuTong that were collected during a random market survey. Five of these products, in addition to the pediatric product Tao Chih Pien reported previously, were found to contain aristolochic acid. Consequently a recall of these products has been issued.

Health Canada is advising consumers of traditional Chinese medicines to read the product labels carefully and to not use products labelled to contain the herbs listed above, as they may contain aristolochic acid. Aristolochic acid can cause cancer, mutations in human cells and is known to cause end-stage kidney failure. To date, no such incidents have been reported in Canada.

Consumers who are currently using products labelled to contain the above mentioned herbs are advised to discontinue use of the product and contact their health care professionals.

Retailers, manufacturers and importers have been directed to recall these products from the shelves. The five additional products found to contain aristolochic acid are as follows:

• Du Xing Quin Li Pill (labelled to contain Clematis Chinesis Osbeck):
  • off-white packaging with green and blue stripes
  • round black pills (3 x 60 capsules)

  • manufacturer: The United Pharmaceutical Manufactory, Kwanchow, China

• Shen Yung Hu (labelled to contain Stephania Tetrandra):
  • orange and white packaging with decorative black panels
  • white round pills (2 x 200 pills)

  • manufacturer: Fu Shun Pharmaceutical Works, China

• Chi Kuan Yen Wan (labelled to contain Fructus Aristolochiae)
  • yellow packaging with white stripe
  • white round pills (2 x 90 pills)

  • manufacturer: Beijing Tung Jen Tang, Beijing, China

• Kuanhsin Suhowan (labelled to contain Radix Aristolochiae)
  • white packaging with blue, red and gold stripes
  • dark brown wax balls ( 120 pills)

  • manufacturer: Shanghai Chinese Medicine Works, Shanghai, China

• Gastropathy (labelled to contain Aristolochia Recurvilabra)
  • white and blue packaging
  • (1 x 42 capsules)
  • manufacturer: Zhengjiang Chinese Medicine Works, Kiangsu, China

On August 24, 2001, Health Canada issued a warning for Tao Chih Pien, the first of the products identified to contain aristolochic acid. There is currently a stop sale order in effect for products labelled to contain the above herbs, which will continue until further notice. Health Canada is maintaining its work with the traditional Chinese medicine industry to resolve issues relating to mislabelling of products and the substitution of herbs in Chinese medicines.

The text in this article was prepared by Health Canada.