Intended for healthcare professionals


Drug safety and regulation

BMJ 2005; 331 doi: (Published 30 June 2005) Cite this as: BMJ 2005;331:4
  1. Patrick C Waller (, consultant in pharmacoepidemiology,
  2. Stephen J W Evans, professor of pharmacoepidemiology,
  3. Keith Beard, consultant physician
  1. Patrick Waller Limited, Southampton SO30 2NY
  2. London School of Hygiene and Tropical Medicine, London WC1E 7HT
  3. Victoria Infirmary, Glasgow G42 9TY

    New powers and resources are needed

    In the past few months, medical journals have published numerous editorials and news items relating to drug safety and regulation.13 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 use similar systems and make similar decisions. If they all …

    View Full Text

    Log in

    Log in through your institution


    * For online subscription