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BMJ 2005;331:4-5 (2 July), doi:10.1136/bmj.331.7507.4
New powers and resources are needed
| The first 150 words of the full text of this article appear below. |
In the past few months, medical journals have published numerous editorials and news items relating to drug safety and regulation.1-3 The withdrawal of rofecoxib (Vioxx) has been the single biggest issue,4 but the cardiovascular safety of other cyclo-oxygenase-2 (COX 2) inhibitors5 and possible suicidal tendencies associated with selective serotonin reuptake inhibitor (SSRI) antidepressants have also raised considerable concerns.6 These high profile cases have resulted in the regulatory bodies responsible for drug safety coming under fire.
From reports in journals it would be easy to get the impression that the US Food and Drug Administration was uniquely at fault over the regulation of COX 2 inhibitors7 and the UK Medicines and Healthcare products Regulatory Agency over paroxetine.3 Given that the regulatory decisions made before and after the marketing of these drugs have been similar throughout the developed world, this can hardly be a logical conclusion. Overall, regulators around the world
Patrick C Waller, consultant in pharmacoepidemiology
Patrick Waller Limited, Southampton SO30 2NY (patrick.waller@btinternet.com)
Stephen J W Evans, professor of pharmacoepidemiology
London School of Hygiene and Tropical Medicine, London WC1E 7HT
Keith Beard, consultant physician
Victoria Infirmary, Glasgow G42 9TY
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