March 1, 2002

The herbal supplement kava, used to treat anxiety, has caused approximately 25 cases of hepatic toxicity, including hepatitis, cirrhosis, and liver failure in Germany, Switzerland, and France. One patient death has been reported and at least one liver transplant was required. The British, Swiss, German, and French governments issued recalls of all kava-containing products and removed kava from the market. Canada issued a consumer alert. The US FDA is asking healthcare professionals to notify the agency of hepatotoxicity possibly related to the use of kava.

Report adverse events to the FDA’s MedWatch program by telephone (1-800-332-1088) or Internet at www.fda.gov/medwatch.