BMJ  2005;330:255-256 (29 January), doi:10.1136/bmj.330.7485.255-c

Letter

Sentinel systems are needed for long term adverse drug reactions

The first 150 words of the full text of this article appear below.

EDITOR—In the wake of the withdrawal of rofecoxib, the limitation of the current system of pharmacovigilance is once again under discussion. With the system's focus on spontaneous reports, unexpected and rare reactions occurring shortly after exposure are usually detected with reasonable sensitivity. However, adverse effects are not readily identified if they occur after long time exposure or manifest themselves as an increase of a common disease. The cardiovascular events caused by rofecoxib belong to the latter group.

Although attractive in theory, the proposal of Dieppe et al to require independent, large scale, randomised trials before definitive drug licensing, is associated with some problems.¹ As Oakley points out,² the sample sizes needed to investigate rare adverse reactions in traditional randomised controlled trials would increase costs for clinical development and ultimately raise drug prices. Furthermore, over time, treatment switches and discontinuations often transform large and simple randomised trials into observational . . . [Full text of this article]

Institute of Public Health, IPH Research Unit of Clinical Pharmacology, University of Southern Denmark, Winslowparken 19, 3rd floor, DK-5000 Odense C, Denmark torbjorncallreus@hotmail.com

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