BMJ  2005;331:4-5 (2 July), doi:10.1136/bmj.331.7507.4

Editorial

Drug safety and regulation

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 . . . [Full text of this article]

Patrick Waller Limited, Southampton SO30 2NY (patrick.waller@btinternet.com)

London School of Hygiene and Tropical Medicine, London WC1E 7HT

Victoria Infirmary, Glasgow G42 9TY

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Audit is important part of drug safety and regulation

Michael I Carter and Jane Murkin
BMJ 2005 331: 456. [Extract] [Full Text]

The influence of big pharma

R E Ferner
BMJ 2005 330: 855-856. [Extract] [Full Text] [PDF]

Suicide, depression, and antidepressants

Andrea Cipriani, Corrado Barbui, and John R Geddes
BMJ 2005 330: 373-374. [Extract] [Full Text] [PDF]

FDA is incapable of protecting US "against another Vioxx"

Jeanne Lenzer
BMJ 2004 329: 1253. [Extract] [Full Text] [PDF]

Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients

Munir Pirmohamed, Sally James, Shaun Meakin, Chris Green, Andrew K Scott, Thomas J Walley, Keith Farrar, B Kevin Park, and Alasdair M Breckenridge
BMJ 2004 329: 15-19. [Abstract] [Full Text] [PDF]

This article has been cited by other articles:

• Carter, M. I, Murkin, J. (2005). Audit is important part of drug safety and regulation. BMJ 331: 456-456 [Full text]  

Rapid Responses:

Read all Rapid Responses

New Model of ADR Monitoring In Indian Medical Institutions

Vikas Dhikav
bmj.com, 2 Jul 2005 [Full text]

Drug Safety and Regulation: Clostridium difficile, antibiotics and PPIs

Michael I Carter, et al.
bmj.com, 16 Jul 2005 [Full text]

Drug safety project in Germany (AMSP). Adverse drug reactions in psychiatry

Detlef Degner, et al.
bmj.com, 26 Jul 2005 [Full text]