Nimesulide associated fulminant hepatic failure

Abstract

PURPOSE: It is controversial whether the non-steroidal inflammatory drug nimesulide is associated with severe hepatotoxicity. Our objective was to determine whether nimesulide is associated with fulminant hepatic failure. METHODS: Retrospective cohort study in the Irish national liver transplant unit. All patients who received a liver transplant for fulminant hepatic failure of unknown cause, between January 1994 and March 2007, were evaluated. New medications started within 6 months prior to transplant were identified. Likelihood of association assessed using the Naranjo and Roussel UCLAF Causality Assessment Method (RUCAM) scoring systems. RESULTS: Thirty-two patients with sero-negative, non-paracetamol fulminant hepatic failure, who received an emergency liver transplant, were identified. Nimesulide had been started within 6 months in 6 patients. Five of the six were middle aged females. Nimesulide was assessed as probably associated with liver injury in all six cases. CONCLUSIONS: Nimesulide was associated with fulminant hepatic failure requiring liver transplant in 6/32 cases of unknown origin. This association requires further investigation.