April 12, 2001
FDA Warns Consumers to Discontinue Use of Botanical Products That
Contain Aristolochic Acid
Washington, DC (SafetyAlerts) - Based on new
information, the Food and Drug Administration (FDA) is advising consumers to immediately
discontinue use of any botanical products containing aristolochic acid. These products may
have been sold as "traditional medicines" or as ingredients in dietary
supplements. Aristolochic acid is found primarily in the plant Aristolochia, but may also
be present in other botanicals. Consumption of products containing aristolochic acid has
been associated with permanent kidney damage, sometimes resulting in kidney failure that
has required kidney dialysis or kidney transplantation. In addition, some patients have
developed certain types of cancers, most often occurring in the urinary tract.
Previously, in May 2000, FDA alerted health care professionals and the dietary supplement
industry of two patients in the United Kingdom who had experienced serious, permanent
kidney damage following the use of botanical products containing aristolochic acid. These
cases, along with the ones previously reported from Belgium and France, resulted in FDA
imposing an import alert to detain botanical ingredients that are either labeled as
"Aristolochia" or, for other reasons, are suspected to contain aristolochic
acid. The ingredient will only be allowed to enter the U.S. when adequate testing shows
that the suspect ingredients are free of aristolochic acid.
Recently, FDA has received reports of two patients in the U.S. who developed serious
kidney disease associated with the use of botanical products that were shown by laboratory
analysis to contain aristolochic acid. In addition, the agency analyzed a sample of 38
botanical products available in the U.S. that were labeled as containing aristolochia or
other herbs that might contain aristolochic acid and found that 18 of these products
contained aristolochic acid. Based on these analytical results, FDA has requested that the
involved U.S. manufacturers or distributors initiate recalls of these products.
Due to the potential serious public health risk, the agency is now advising consumers to
stop using any products that may likely contain aristolochic acid. This includes products
with the words "Aristolochia," "Bragantia" or "Asarum"
listed as ingredients on the label, or any of the products FDA has found to contain
aristolochic acid (see list of the 18 products analyzed by FDA -
www.cfsan.fda.gov/~dms/ds-bot3.html). Consumers cannot be assured that products containing
these ingredients are free of aristolochic acid unless they have been tested in a
laboratory. To inquire about whether appropriate testing has been done, consumers may wish
to contact the manufacturer or distributor of the product.
FDA advises consumers who have taken any of these products of concern to contact their
health care provider immediately. Even if these products have not been used recently,
consumers should still inform their health care provider about which product they took, so
that an appropriate evaluation may be conducted.
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