Monitoring the safety of licensed medicines.
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.
Breckenridge
Alasdair
A
Medicines and Healthcare Products Regulatory Agency London UK, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK. Alasdair.Breckenridge@mhra.gsi.gov.uk
Woods
Kent
K
Raine
June
J
D016208:Databases, Factual; D006801:Humans; D011358:Product Surveillance, Postmarketing; D006113:United Kingdom; D014481:United States