Monitoring the safety of licensed medicines

Abstract

The withdrawal of the selective cyclooxygenase 2 inhibitor rofecoxib owing to cardiovascular side effects ignited debate about the need for major changes to current mechanisms for post-marketing surveillance (PMS) of drug safety. Here, we discuss the current mechanisms, whether they are being used appropriately, and consider the need for changes to regulatory systems.

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Correspondence to Alasdair Breckenridge.

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Medicines and Healthcare products Regulatory Agency

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Breckenridge, A., Woods, K. & Raine, J. Monitoring the safety of licensed medicines. Nat Rev Drug Discov 4, 541–543 (2005). https://doi.org/10.1038/nrd1778

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