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Nimesulide

I have every sympathy with K Weerasuriya's final sentiment (June 19, p 2162)1 that health should come before trade and that rapid registration of new drugs should not be at the expense of proper evaluation. However, I must make two comments about the particular example Weerasuriya chose, the anti-inflammatory, nimesulide<br>

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Nimesulide

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  1. Nimesulide I have every sympathy with K Weerasuriya's final sentiment (June 19, p 2162)1 that health should come before trade and that rapid registration of new drugs should not be at the expense of proper evaluation. However, I must make two comments about the particular example Weerasuriya chose, the anti-inflammatory, nimesulide

  2. Nimesulide is described as a selective inhibitor of cyclo-oxygenase-2 (COX-2) in the same sentence as it is given as a cause of fulminant hepatic failure. Nimesulide is not a selective COX-2 inhibitor, compared with the two recently introduced selective COX-2 inhibitors, celecoxib, and rofecoxib that have inhibitor selectivities well in excess of that of nimesulide.

  3. Thus, any correlation between COX-2 inhibition and hepatic injury which could easily be inferred from Weerasuriya's sentence, would be entirely unjustified. A fear of hepatic injury from these new compounds could dissuade many patients with rheumatoid arthritis or osteoarthritis and their prescribers from a much greater possibility of real clinical benefit.

  4. Weerasuriya's treatment of nimesulide is unfair. It is not a “me-too” non-steroidal anti-inflammatory drug (NSAID). This compound exhibits significant clinical differences from other NSAIDs.4 For example, nimesulide has been used successfully in aspirin-sensitive asthmatics and in premature labour, disorders in which other NSAIDs are not tolerated.

  5. The cases of hepatic failure should be balanced against the long and successful experience with nimesulide in many European and South American countries.I agree there is no substitute for a proper examination of the data offered in support of any candidate for drug registration and it is not enough to rely on the simple fact of registration in other countries.

  6. But it is also illogical to rely on the lack of registration or on isolated reports of toxicities or on difficulties that may be resolved by written changes in the summary of product characteristics,5 as a basis for rejection. Finally, let me assure you I am not a consultant for any of the many sellers of nimesulide, celecoxib, or rofecoxib.

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