Pharmacy Daily | EMA NSAID review

THE European Medicines Agency (EMA) has begun a review of the cardiovascular safety of nonselective NSAIDs (non-steroidal anti-inflammatory drugs). The Agency’s Committee for Medicinal Products for Human Use last reviewed the cardiovascular safety of non-selective NSAIDs in 2006, and concluded that overall the NSAID benefit-risk balance remained positive, despite a small increased risk of thrombotic events such as heart attacks or stroke (particularly with long-term high dose usage). The result of this 2006 review however saw the creation of the Safety Of Non-Steroidal Anti- Inflammatory Drugs Project, funded by the European Union, and whose research is now the focus of the new 2011 EMA review. Of particular interest to the EMA is the Project’s latest paper titled ‘Stroke risk and NSAIDs: a systematic review of observational studies’ which looked at observational studies on the risk of stroke associated with the use of individual NSAIDs, and found evidence of an increased risk of ischemic stroke with the current use of rofecoxib and diclofenac

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