FDA: Chinese Herb Causes Kidney Failure, Cancer
WebMD News Archive
Similar cases have also been found in the United Kingdom and in France, prompting the FDA, in May 2000, to impose an import alert on products labeled "aristolochia" or believed to contain aristolochic acid, and to alert healthcare professionals in this country.
Recently, the FDA received reports of two patients in the U.S. who developed serious kidney disease associated with the use of products containing aristolochic acid. One patient had a kidney transplant, and the second is awaiting one. The FDA is asking healthcare professionals to report cases of kidney disease or cancers associated with the use of this product.
Some in the supplement industry are glad the FDA is sounding the warning on aristolochia.
Aristolochic acid is known to damage the kidneys and cause cancer, Gail Engels tells WebMD.
"We feel like there is very little to support the benefits and much to be concerned about," says Engels, communications director at the American Botanical Council, a nonprofit educational organization promoting the responsible use of medicinal plants.
"When this first came up again, a few months ago, a lot of companies automatically, voluntarily took their product off the market," she says, adding that some manufacturers and distributors have not pulled their products. "We just feel like there are a lot of issues right now about herbs; defending carcinogens right now just isn't something we want to do."
But there is a larger issue underlying the health problems associated with this one particular extract. Last year, in the same issue of the New England Journal of Medicine that contained a study on the Belgian patients, FDA Commissioner David Kessler, MD, blasted the controversial Dietary Supplement Health and Education Act of 1994 for allowing the supplement industry to escape regulation.
While the number of problems related to aristolochic acid has been on the rise throughout the 1990s, Kessler wrote, the FDA had -- up to that point -- failed to respond. Kessler made the point that, beyond the problems linked to this individual extract, the current system is badly in need of an overhaul, adding that dietary supplements (unlike drugs) don't have to be shown to be safe and effective before being allowed on the market.