Nimesulide and renal impairment

Objectives: To analyse from spontaneous reporting data the renal adverse re actions associated with the use of nimesulide. Methods: Case reports were obtained from a Northern Italian Regional databa se (Veneto Pharmacovigilance System), containing all the spontaneous report s filed between 1988 and 1997. The Veneto Region is the principal contribut or to the Italian spontaneous reporting system, with an annual report rate of approximately 17 per 100 000 inhabitants. The clinical records of hospit alized patients were also analysed. Results: Of the 120 reports associated with oral nimesulidel 11 referred to suspected renal adverse reactions. The drug was taken by ten patients for a short period. All the patients discontinued the therapy and hospitalizati on was required in six cases. Other risk factors were identified in six cas es. Discussion: Together with the new insights into the possible consequences o f renal cyclooxygenase-2 (COX-2) inhibition, the reported cases should draw the attention of doctors and patients to the importance of recognizing any possible signs of renal impairment during nimesulide therapy, although onl y extensive epidemiological data can define the real impact of its renal to xicity.