arznei-telegramm 2002; 33: 2



The Bundesinstitut fŘr Arzneimittel und Medizinprodukte, BfArM (Federal Institute for Drugs and Medical Devices) views the marketing of kava-kava (piper methysticum) compounds as "unwarranted" due to its hepatic toxicity. Therefore, two months ago BfArM announced, that it intends to withdraw all registration and licensing of these products (a-t 2001; 32: 121). Thirty reports of liver damage associated with kava-kava or kavaine-containing products have been published in Germany and Switzerland, including six reports of liver failure (requiring liver transplants in four cases, one death). These reports led to a variety of reactions across many nations. Thus, at the beginning of this year, France has put the registration of kava products on hold - at least for one year. The French Drug Administration recommends to stop immediately the use of any kava-kava products, referring to the reports issued in Germany and Switzerland. An exception to this recommendation refers to homeopathic solutions that are highly diluted ("potentiated"; Agence franšaise de sÚcuritÚ sanitaire des produits de santÚ: press release, dated 9 January 2002). The US-American Food and Drug Administration, FDA, received several reports of severe hepatotoxic damage associated with kava-kava containing food supplements, including at least one report of liver failure requiring liver transplantation in a previously healthy young woman. The FDA has addressed US physicians in order to obtain further reports of adverse events with kava-kava products (FDA letter dated 19 December 2001*). The Canadian Department of Health advises its citizens to abstain from using any kava-kava products until the Office decides on appropriate measures to be taken (Health Canada: Advisory of 16 January 2002**). In Germany, a final decision from BfArM is still missing. Upon an initiative taken by the manufacturers, kava-kava products will become available by prescription only (as of 1 July 2002 at the earliest). It seems that the production companies intend to prevent the worst.



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