Kava
This article was originally published in The Tan Sheet
Executive Summary
Recent European AERs linking herbal to hepatotoxicity prompt NCCAM to suspend two sponsored trials underway at Duke University Jan. 7, pending guidance from FDA's investigation into the botanical's safety. Trial that began in July 2000 is comparing kava to Wyeth's Effexor XR (venelafaxine) in 124 generalized anxiety disorder patients. Second study, which began in July 2001, is exploring kava use in 48 patients with performance anxiety related to public speaking. A 1Jan. 16 Health Canada advisory urges consumers to avoid kava use while agency reviews safety, effectiveness data; New Zealand's Ministry of Health also is undertaking "limited" toxicological review. In Jan. 14 statement, AHPA advises consumers not to use kava if currently taking Rx or OTC drugs and to discontinue use if jaundice symptoms develop...
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Health Canada is "requiring Canadian manufacturers, distributors and importers to stop the sale of kava-containing products" and requests these products be recalled from "all levels of the market," according to an 1Aug. 21 advisory. Announcement follows safety assessment of worldwide reports of liver toxicity associated with herbal (2"The Tan Sheet" Jan. 21, 2002, In Brief). Separately, Australia's Therapeutic Goods Administration initiated a voluntary kava recall Aug. 15 following the death of an Australian woman who took the herbal, likely with other botanicals, for four months...
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