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