| U.S. Food and Drug Administration |
FDA News Release, Dec 19, 2001
Letter to Health Care Professionals Regarding Potential Health Hazards Associated With Kava.
Dear Health Care Professional Colleague:
The Food and Drug Administration (FDA) needs your help. The agency is
investigating whether the use of dietary supplements containing kava (also known
as kava kava or Piper methysticum) is associated with liver toxicity. To help us
determine whether there is a problem in the United States, we are asking that
you review your cases of liver toxicity to determine if any may be related to
the use of kava-containing dietary supplements.
Products containing herbal extracts of kava have been implicated in cases of
serious liver toxicity in Germany and Switzerland. Approximately 25 reports of
hepatic toxicity associated with the use of products containing kava extracts
have been reported in these countries. Serious hepatic adverse effects include
hepatitis, cirrhosis, and liver failure. At least one patient required a liver
transplant. Based on their assessment of the adverse events reported to them,
the regulatory authority in Switzerland has prohibited the sale of products
containing the kava extract associated with the adverse effects. Last month, the
German authorities issued a proposal to remove all kava extract-containing
products from the market.
FDA is investigating whether the use of kava-containing dietary supplements
in the United States poses similar public health concerns. The agency has
received several reports of serious injury allegedly associated with the use of
kava-containing dietary supplements, with at least one report of hepatic failure
requiring liver transplantation in a previously healthy young female.
Dietary supplements containing kava are promoted for a variety of uses,
including relaxation (e.g., to relieve stress, anxiety, and tension), insomnia,
and postmenstrual syndrome (PMS). The products are marketed to all segments of
the population, including children, women, men, and the elderly.
Due to the potentially serious nature of these concerns, we urge you to
report any cases of hepatic toxicity that you think may be related to the use of
kava-containing dietary supplements. Adverse events associated with the use of
dietary supplements should be reported as soon as possible to FDA's MedWatch
program at 1-800-332-1088.
Thank you in advance for your cooperation in assisting the FDA in
investigating this potentially serious public health issue.
Sincerely yours,
Christine Lewis Taylor, Ph.D.
Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This letter was prepared by the FDA Center for Food Safety and Applied Nutrition.