
Safety of Aristolochic Acid
Bernard A. Schwetz, DVM,PhD
JAMA. 2001;285:2705.
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The FDA has alerted health care professionals to important safety information about botanical products containing aristolochic acid, which are used as ingredients in dietary supplements or sold as "traditional medicines."
A year ago, the agency informed health care professionals that consumption of products with aristolochic acid resulted in several life-threatening adverse events and urged manufacturers and distributors of dietary supplements to ensure that their products are free of this harmful ingredient.
Since then, there have been additional reports of serious adverse events involving products containing aristolochic acid, including the following:
- A study in Belgium has found that among 39 patients with end-stage renal failure, 18 cases of urothelial tract carcinoma occurred. All analyzed tissue samples contained aristolochic acidrelated DNA adducts.
- FDA laboratory analyses revealed the presence of aristolochic acid in certain botanical products and dietary supplements sold in the United States. Some of the products were . . . [Full Text of this Article]
Acting Principal Deputy Commissioner Food and Drug Administration
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