Perspectives
Nature Reviews Drug Discovery 4, 541-543 (July 2005) | doi:10.1038/nrd1778
Essay: Monitoring the safety of licensed medicines
Alasdair Breckenridge1, Kent Woods1 & June Raine1 About the authors
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.
Author affiliations
- Alasdair Breckenridge, Kent Woods and June Raine are at the Medicines and Healthcare products Regulatory Agency, London UK. Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
Correspondence to: Alasdair Breckenridge1 Email: Alasdair.Breckenridge@mhra.gsi.gov.uk
Published online 24 June 2005
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