Lessons from the withdrawal of rofecoxib

doi:10.1136/bmj.329.7471.867

BMJ 2004;329:867-868 (16 October), doi:10.1136/bmj.329.7471.867

Editorial

Lessons from the withdrawal of rofecoxib

Patients would be safer if drug companies disclosed adverseevents before licensing

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

The history of the development and marketing of non-steroidalanti-inflammatory drugs is both fascinating and frightening.It offers a strange combination of stunning commercial successesand dramatic calamities, the latest concerning the recentlywithdrawn drug rofecoxib (Vioxx).¹

In the 1960s research showed that salicylates were good forpain relief in rheumatoid arthritis, but as with steroids, theiruse was limited by toxicity.² So the major pharmaceutical companiesdeveloped non-salicylate, non-steroidal anti-inflammatory drugs(NSAIDs). Over the subsequent 40 years we have seen a processionof new agents come and go, each one being heralded as eithermore efficacious or less toxic than its competitors. As newNSAIDs appeared, the indications steadily broadened from inflammatorydiseases to almost any painful condition. Each time a new drugwas launched the market expanded, resulting in annual estimatedsales of more than $20bn (£11.1bn; ${euro}$ 16.1bn) worldwide.²

The first big problem with a new NSAID occurred . . . [Full text of this article]

Paul A Dieppe, director

MRC Health Services Research Collaboration, University of Bristol, Bristol BS8 2PR (p.dieppe@bristol.ac.uk)

Shah Ebrahim, head of department, Richard M Martin, senior lecturer in epidemology and public health

Department of Social Medicine, University of Bristol

Peter Jüni, senior research fellow in clinical epidemiology

Departments of Social and Preventive Medicine and Rheumatology, University of Berne, CH-3012 Berne, Switzerland

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