Botanical Product May Lead to Kidney Damage or Cancer - Brief Article

AORN Journal, August, 2001

Consumers are advised to immediately discontinue use of any botanical product containing aristolochic acid, according to an April 11, 2001, news release from the US Food and Drug Administration (FDA). Products containing the ingredient may have been sold as traditional medicines or ingredients in dietary supplements. Consuming products containing aristolochic acid may lead to permanent kidney damage or certain types of cancer.

Two cases of permanent kidney damage from use of the ingredient that occurred in the United Kingdom led the FDA to impose an alert to detain botanical ingredients labeled as Aristolochia or those suspected of containing aristolochic acid. The ingredient will be allowed into the United States only after testing shows the suspect product is aristolochic acid-free.

Reports of two US patients who developed serious kidney disease associated with the use of aristolochic acid have been received, according to the release. Additionally, testing of 38 botanical products available in the United States labeled as containing Aristolochia revealed that these products contain aristolochic acid. Based on this information, the FDA is asking manufacturers and distributors to recall these products.

The FDA is warning consumers to discontinue use of any products labeled as containing Aristolochia, bragantia, or asarum. The only way to determine if products containing these ingredients are free of aristolochic acid is to have them laboratory tested. To determine if a product has been tested, contact the manufacturer or distributor. According to the release, the FDA also is urging consumers who have taken any of these products to visit their health care providers immediately.

FDA Warns Consumers to Discontinue Use of Botanical Products That Contain Aristolochic Acid (news release, Rockville, MD: US Food end Drug Administration, April 11, 2001) http://www.cfsan.fda.gov/~dms/ (accessed 17 April 2001).