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BMJ 2003;327:1050-1051 (1 November), doi:10.1136/bmj.327.7422.1050-c
| The first 150 words of the full text of this article appear below. |
EDITORTraversa et al studied the hepatoxicity of nimesulide and other nonsteroidal anti-inflammatory drugs (NSAIDs).1 Nimesulide may arguably have a small risk of the more severe hepatic injuries with an odds ratio of 1.9 (95% confidence interval 1.1 to 3.81). Since the drug is widely used in Italy the population attributable risk could account for a number of avoidable cases.2
The characteristics of users of the different NSAIDs were assumed to be similar on the basis of the numbers of packets per prescription. If, rather than the number of packets, the number of defined daily doses per person had been useda more reliable approachthe conclusion would have been different since the mean number of defined daily doses per user of nimesulide and NSAIDs were 50.9 and 73.2, respectively.
A substantial proportion of nimesulide induced hepatotoxicity occurred after a comparatively long time of exposure. In Spain five of the 11
Alfonso Carvajal, professor of pharmacology
Instituto de Farmacoepidemiología, Ramán y Cajal, 7, E-47005 Valladolid, Spain carvajal@ife.uva.es
Miguel Angel Maciá, clinical pharmacologist
Pharmacovigilance Centre of Castilla-La Mancha, Toledo, Spain
Javier García del Pozo, pharmacist, Francisco de Abajo, head
Spanish Medicines Agency, Madrid, Spain