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Monitoring the safety of licensed medicines

Nature Reviews Drug Discovery volume 4, pages 541–543 (2005)Cite this article

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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Author information

Authors and Affiliations

  1. Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London, London, SW8 5NQ, UK

    Alasdair Breckenridge, Kent Woods & June Raine

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  1. Alasdair Breckenridge
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  2. Kent Woods
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  3. June Raine
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Corresponding author

Correspondence to Alasdair Breckenridge.

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The authors declare no competing financial interests.

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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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