The FDA has issued a strong warning to consumers to avoid herbs containing the chemical aristolochic acid. These herbs have the potential to cause cancer of the urinary tract and permanent kidney failure. Anyone who has consumed the herbal products listed in the bottom of this MedicineNet.com Alert should discontinue the product immediately and contact their doctor for further evaluation.
William
Shiel, MD, FAAP, FACR
Chief Medical Editor, MedicineNet.com
FDA WARNS CONSUMERS TO DISCONTINUE USE OF
BOTANICAL PRODUCTS THAT CONTAIN ARISTOLOCHIC ACID
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 16 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.
Current and past FDA activities
and actions associated with aristolochic acid may be found at:
www.cfsan.fda.gov/~dms/ds-bot.html
Here is a
listing of some herbal products containing aristolochic acid:
| Product Name |
Responsible Firm |
| Rheumixx | PharmaBotanixx, Irvine, CA (Distributor), Sun Ten Laboratories, Inc., Irvine, CA (Manufacturer) |
BioSlim Doctor's Natural Weight Loss System Slim Tone Formula |
Thane International, LaQuinta, CA (Distributor) |
| Prostatin | Herbal Doctor Remedies, Monterey Park, CA (Distributor) |
| Fang Ji Stephania | Lotus Herbs Inc., LaPuente, CA (Distributor) |
| Mu Tong Clematis armandi | Lotus Herbs Inc., LaPuente, CA (Distributor) |
| Meridian Circulation | East Earth Herb Inc. (Brand name Jade Pharmacy), Eugene, OR |
| Temple of Heaven Chinese Herbs Radix aristolochiae | Mayway Corporation, Oakland, CA (Distributor) and Almira Alchemy, Alachua, FL (Distributor) |
Qualiherb Chinese Herbal Formulas Dianthus Formulas Ba Zheng San |
QualiHerb (Division of Finemost), Cerritos, CA (Distributor) |
Clematis & Carthamus Formula 21280 (2 samples) |
QualiHerb (Division of Finemost), Cerritos, CA (Distributor) |
Virginia Snake Root, Cut Aristolochia serpentaria (2 samples) |
Penn Herb Co., Philadelphia, PA (Manufacturer) |
| Green Kingdom Akebia Extract | Green Kingdom Herbs, Bay City, MI (Manufacturer) Ava Health, Grove City, OH (Distributor) |
| Green Kingdom Stephania Extract | Green Kingdom Herbs, Bay City, MI Ava Health (Distributor) |
| Neo Concept Aller Relief | BMK International, Inc., Wellesley, MA (Distributor), Sun Ten Labs, Irvine, CA (Manufacturer) |
| Mu Tong Clematis armandi | Botanicum.com, Winnipeg, Canada and Pembina, ND |
| Fang Ji Stephania | Botanicum.com, Winnipeg, Canada and Pembina, ND |
Stephania tetrandra, roots, whole (1) Product labeling states "Not for human consumption." |
Ethnobotanical, Racine, WI |
Joint Ease/Joint Comfort Complex |
not available |
Source: http://www.cfsan.fda.gov
Health Solutions From Our Sponsors