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BEWARE of Aristolochic Acid

American Fitness, July, 2001

On May 31, 2000, the Food and Drug Administration issued a letter to health care professionals concerning the nephrotoxicity and carcinogenicity of botanical products containing aristolochic acid. During this time, the FDA also issued a letter to representatives of the dietary supplement trade associations, urging them to review their manufacturing procedures and ensure botanical products are free of aristolochic acid. In addition, the FDA issued an import alert providing for the detention of any botanical ingredients containing the plant Aristolochia. These actions were the result of several alarming factors.

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In Belgium, there has been approximately 100 reported cases of renal disease in patients who participated in a "slimming regimen" from 1990 to 1992. This "slimming regimen" included a weight-reducing pill containing powdered herbs. The major pathological lesion consisted of extensive renal interstitial fibrosis with atrophy and loss of tubules. At least 70 of these patients have required either dialysis or transplantation.

It was concluded that one of the botanicals (Stephania tetrandra) had been inadvertently substituted with Aristolochia fangchi (a botanical known to contain aristolochic acid), because of the close similarity in the Chinese names. In 1996, aristolochic acid-related DNA adducts were detected in renal tissue from five of the original Belgian patients.[1]

In August 1999, two new cases of interstitial fibrosis, in which the patients had consumed botanical preparations containing aristolochic acid, were reported from the United Kingdom. Both patients developed end-stage renal failure; one has received a transplant and the other is awaiting one.[2]

Since then, a study conducted in Belgium reported that among 39 patients with end-stage renal failure, from the original Belgian cohort who agreed to undergo prophylactic surgery, there were 18 cases (46%) of urothelial carcinoma. All tissue samples analyzed contained aristolochic acid-related DNA adducts. The authors concluded that "aristolochia toxins (aristolochic acids and possibly other derivatives) cause renal disease and urothelial cancer."[3]

Seven cases, similar to the Belgian cases, were identified in France, corresponding to exposure to botanical preparations contaminated with Aristolochia fangchi from 1989 to 1992. In May 2000, a case of urothelial carcinoma was diagnosed in one these patients. A second case of urothelial carcinoma is suspected a third patient, lymphoma on a graft was detected. (Communication the French Medical Products Safety Agency; October 27, 2000)

FDA laboratory analyses of certain botanical products, sold in the United States, revealed the presence of aristolochic acid. These include single-ingredient products labeled as Aristolochia (e.g., Stephania tetrandra, Clematis armandii and Akebia extract). In addition, aristolochic acid was detected in several finished products sold as dietary supplements. As a result, warning letters and requests for recalls were issued to the various manufacturers or distributors involved.

In the United States, two patients who developed end-stage renal disease in association with the use of botanical preparations containing aristolochic acid have been recently reported. The first patient began using herbal "medicines" in 1994. She progressed to end-stage renal disease within eight months. A renal biopsy showed extensive interstitial fibrosis with focal lymphocytic infiltration. A renal transplant was performed in 1996. Laboratory analyses of the patient's botanical products, conducted in Belgium, indicated the presence of aristolochic acid in two of the products she had been using.[4]

The second patient consumed a botanical product called "Stephania tablets" for approximately two years, until 1994. She was recently diagnosed with end-stage renal disease and is awaiting a renal transplant. Laboratory analysis by the California Department of Health Services showed the botanical product to contain aristolochic acid. Although the product was labeled as containing the herb Stephania tetrandra, it is likely that Aristolochia fangchi had been substituted for it, thereby accounting for the presence of aristolochic acid in the product.

Cases of renal disease or malignancies associated with the use of botanical preparations should be reported immediately to FDA's MedWatch program by calling (800) 332-1088 or visiting www.fda.gov/medwatch.

[1] HH Schmeiser et al., "Detection of DNA adducts formed by aristolochic acid in renal tissue from patients with Chinese herbs nephropathy," Cancer Res 56 (1996) : 2025-8.

[2] GM Lord et al., "Nephropathy caused by Chinese herbs in the UK," Lancet 354 (1999) : 481-2.

[3] JL Nortier et al., "Urothelial carcinoma associated with the use of a Chinese herb, Aristolochia fangchi," New England Journal of Medicine 342 (2000) : 1686-92.

[4] MM Meyer et al., "Chinese herb nephropathy," Baylor Univ Med Center Proc 13 (2000) : 334-7.

BEWARE of Aristolochic Acid

American Fitness, July, 2001

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