Nimesulide associated fulminant hepatic failure

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.

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.

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.

Nimesulide was associated with fulminant hepatic failure requiring liver transplant in 6/32 cases of unknown origin. This association requires further investigation.