Primeras notificaciones espontáneas de sospechas de reacciones adversas a los nuevos antiinflamatorios selectivos sobre la ciclooxigenasa-2

Fundamento: Los nuevos antiinflamatorios no esteroides (AINE) inhibidores selectivos de la ciclooxigenasa 2 se han asociado a una menor incidencia de efectos adversos gastrointestinales. Material y método: Se revisan las primeras notificaciones de efectos adversos de rofecoxib y celecoxib recibidas en el Centro de Farmacovigilancia de Cataluña, y se comparan con las relativas a AINE clásicos. Resultados: Los efectos adversos más frecuentes de rofecoxib fueron digestivos y cardiovasculares; los de celecoxib, cutáneos y digestivos, y los de AINE clásicos, digestivos y neuropsiquiátricos. Conclusiones: Rofecoxib y celecoxib no están exentos de toxicidad digestiva y pueden dar lugar a efectos adversos cardiovasculares.

Background: The new selective cyclooxygenase 2 non-steroidal anti-inflammatory drugs (NSAIDs) have been associated with a lower incidence of adverse gastrointestinal effects. Material and method: The first Yellow Cards received at the Catalan Centre of Pharmacovigilance reporting adverse effects of rofecoxib and celecoxib were reviewed and compared to those attributed to non-selective NSAIDs. Results: Most frequent adverse effects of rofecoxib were gastrointestinal and cardiovascular; those of celecoxib were mostly cutaneous and gastrointestinal; and those of non-selective NSAIDs were gastrointestinal and neuropsychiatric. Conclusions: Rofecoxib and celecoxib are not devoid of gastrointestinal toxicity; they may also induce cardiovascular adverse effects.