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Britain may ban kava, U.S. will study
LONDON, July 19 (UPI) -- A British government agency is considering banning the herbal remedy kava because it has been linked with severe liver toxicity, but the move probably will not prompt the United States to do the same as it keeps a watchful eye over the situation, officials told United Press International. In a letter dated Thursday, the chairman of the advisory panel the Committee on Safety of Medicines recommended prohibiting the sale, import, and supply of unlicensed products containing kava in the United Kingdom after reports of 68 cases of liver toxicity worldwide resulting in six liver transplants and three deaths. There have been three cases of severe liver side effects among kava users in England. The move comes shortly after the German government revoked the licenses of authorized products containing kava kava because of health concerns. CSM Chairman Professor Alasdair Breckenridge told UPI other European countries have implemented strict regulations on kava. "In France, Portugal and Spain, kava products have been suspended, with the exception of some homeopathic preparations," Breckenridge said. "There has also been a voluntary withdrawal of kava kava products by the herbal sector in Ireland." Despite events across the Atlantic, U.S. rules on kava remain unchanged, though the government, independent organizations and scientific experts are keeping in contact with European scientists and officials regarding kava's potential side effects. There are no plans to recommend banning products containing kava. "The FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury and will alert consumers, if necessary, when more information becomes available," a Food and Drug Administration official told UPI. An FDA advisory bulletin on March 25 warned consumers about kava. "Liver-related risks associated with the use of kava have prompted regulatory agencies in other countries, including those in Germany, Switzerland, France, Canada, and the United Kingdom, to take action," the bulletin said. "Although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk." To date, the FDA has received one report of a young healthy female kava user who required a liver transplant and several other reports of kava users developing liver problems, such as jaundice. However, Mark Blumenthal, founder and executive director of the American Botanical Council and a professor at the College of Pharmacy at the University of Texas at Austin, said a cause-and-effect relationship between kava use and liver complications has not been established. "Most of the cases being reported are associated with people who have pre-existing liver disease or (use) kava and alcohol," or people who took kava with prescription medications that should not be combined with the herb, Blumenthal told UPI. "When you look at the number of kava cases reported tied to liver effects and you look at the number of millions of dosages that are used, some reports suggest kava is no worse than some of the drugs prescribed for anxiety." Kava -- also called kava kava -- is an herb indigenous to the South Pacific and is used primarily to treat insomnia and anxiety. Throughout the South Pacific, it is drunk frequently as a tea and there have been few incidences of liver problems, Blumenthal explained. Because herbal remedies can be bought anywhere, he said, it is likely there will be more reports of side effects among kava users because they could be taking the supplement inappropriately. "Why not have proper warning labels on herbs?" he said. "The FDA has not in some cases fully exercised its authority in the area of regulating herbs." Under the 1994 Dietary Supplement Health and Education Act, herbal products are not required to be tested scientifically for safety or efficacy as is required by the FDA of all drugs sold in the U.S. market. In Europe, many herbs are more tightly regulated and often are prescribed by physicians and dispensed through pharmacies, though anyone can purchase supplements on the Internet at their own risk. "People shouldn't self-prescribe kava," said Lise Alschuler, clinical medical director at Bastyr University, in Seattle, a school devoted to the study of naturopathic and botanical medicine. "Kava, the herb itself is not inherently dangerous." However, patients taking kava should do so under their doctor's supervision, she said. Because of Europe's regulations over dietary supplements, there is more accurate reporting of side effects among supplement users, Alschuler explained. It is possible problems linked to kava use could be underreported in this country. "We're certainly looking at the data in Europe and from that, we're being cautious," she said. But banning kava products appears heavy-handed, Alschuler added. "The recommendation that's coming out of England is a bit of a over-reaction."

posted by West 6:06 PM