FDA Sends out a message to Health Care Professionals about Kava Kava
FDA Sends out a message to Health Care Professionals about Kava Kava
(SafetyAlerts) - The cooking.net">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 by telephone (1-800-332-1088) or
through the Internet ( http://www.***.com/ ).
Thank you in advance for your cooperation in assisting the FDA in investigating this
potentially serious public health issue. For additional information, contact Steven
Gitterman, M.D., Ph.D. at (301) 436-2371.
Sincerely yours,
Christine Lewis Taylor, Ph.D.
Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for cooking.net">food Safety and Applied Nutrition .
Source: FDA.
