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Rev Med Liege. 2004 Oct;59(10):565-9.

[Withdrawal of rofecoxib (Vioxx): what about cardiovascular safety of COX-2 selective non-steroidal anti-inflammatory drugs?].

[Article in French]

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Université de Liège, Chef de Service, Service de Diabétologie, Nutrition et Maladies métaboliques et Service de Médecine interne générale, CHU Sart Tilman, Liège.


Rofecoxib (Vioxx), the first COX-2 selective non-steroidal anti-inflammatory drug (NSAID), was recently withdrawn by Merck Sharp & Dohme. Indeed, both observational studies and randomised clinical trials showed that rofecoxib is associated with a significantly increased risk of acute myocardial infarction in patients receiving either high daily dosage (>25 mg/day) or for a long period of time (> 18 months). The precise mechanism responsible for this phenomenon still remains unknown. Currently available data suggest that this adverse effect is not observed with other COX-2 NSAIDs, especially celecoxib for which the information is most abundant. Nevertheless, caution is required because of lack of prospective long-term data, and strict respect of indications and modalities of clinical use of COX-2 NSAIDs is mandatory. Finally, in patients with high cardiovascular risk who should receive a COX-2 selective NSAID, the association with a low dose of acetylsalicylic acid is recommended in order to benefit of a protective antiplatelet effect.

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