Avandia remains an option in the US
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Avandia remains an option in the US A US FDA advisory panel has voted in favour of the continued availability of Avandia [rosiglitazone] in the US market, reports the drug’s manufacturer GlaxoSmithKline.1 In making the 22–1 decision, the Endocrinologic and Metabolic Drugs, and Drug Safety and Risk Management Advisory Committees did note that the data suggest some ischaemic risk associated with Avandia but declined to comment on Avandia’s comparative risk to other oral antihyperglycaemic agents. The FDA’s briefing documents show that the agency’s analyses yielded odds ratios (ORs) for myocardial infarction with rosiglitazone of 1.6 (p = 0.02) and 0.8 (p = 0.8) versus placebo and other antihyperglycaemic agents, respectively.2 The OR of 1.6 is mainly driven by data from rosiglitazone plus metformin trials. Rosiglitazone monotherapy yielded a nonsignificant OR of 1.2 (0.6, 2.8) versus placebo. 1. GlaxoSmithKline. FDA Advisory Panel Votes 22 to 1 for Avandia(R) to Remain Available to Patients in the US. Media Release : 30 Jul 2007. Available from: URL: http://www.gsk.com. 2. FDA. FDA Briefing Document: Division of Metabolism and Endocrine Products and Office of Surveillance and Epidemiology. Internet Document : [436 pages], 30 Jul 2007. Available from: URL: http://www.fda.gov. 801069576
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Reactions 4 Aug 2007 No. 1163
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