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| * ava * ava pepper * awa * intoxicating pepper * kava * kava kava * kava pepper * kava root * kava-kava * kawa |
* kawa kawa * kawa-kawa * kew * Piper methysticum * Piper methysticum Forst.f. * Piper methysticum G. Forst. * rauschpfeffer * sakau * tonga * wurzelstock * yangona |
FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury. The agency's investigation includes attempting to determine a biological explanation for the relationship and to identify the different sources of kava in the U.S. and Europe. The agency will alert consumers, and if warranted, take additional action as more information becomes available.
Also, FDA informs healthcare professionals that products containing herbal extracts of kava have been implicated in Europe in at least 25 cases of serious liver toxicity including hepatitis, cirrhosis, and liver failure. 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 (here). (more)
Kava Links
FDA/CFSAN Consumer Advisory: Kava (more)
It is now official in the United States. The U.S. Food and Drug Administration has issued a warning about the potential for serious liver damage and toxicity, in some cases requiring liver transplant, if you use kava (more)
FDA investigating kava kava (more)
FDA information on dietary supplements (more)
Kava May Cause Liver Damage (more)
'Emotional aspirin' herb may damage the liver Kava, an herb that's supposed to make you feel relaxed, has been banned in two European countries because of possible liver toxicity. (more)
Drugs that pose a risk to the liver Fort Worth Star-Telegram (here)
Feel-good kava has a down side
Herbal Remedies: Natural Does Not Mean Safe
To report Kava side effects go here
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