The EMA is to start a new review of the CV* risks associated with non-selective NSAIDs.
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■ The EMA is to start a new review of the CV* risks associated with non-selective NSAIDs. In 2006, the Agency’s CHMP concluded that the overall benefit-risk balance of the drugs remained positive, but recommended that the European Commission fund an independent epidemiological study to further assess the long-term CV and GI toxicity of the drugs. The results of this independent meta-analysis, and of several other new studies on the CV safety of NSAIDs, have been published recently. The CHMP will thoroughly review these data, and any other available clinical data and postmarketing safety reports on nonselective NSAIDs, to decide whether its 2006 opinion needs updating. * cardiovascular See also Reactions 1372, p4; 801161098. EMA. European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs. Media Release : 21 Oct 2011. Available from: URL: 809130084 http://www.ema.europa.eu
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Reactions 29 Oct 2011 No. 1375
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