Nimesulide and renal impairment

• Published in: European journal of clinical pharmacology Vol. 55; no. 2; pp. 151 - 154
• Main Authors: LEONE, R, CONFORTI, A, GHIOTTO, E, MORETTI, U, VALVO, E, VELO, G. P
• Format: Journal Article
• Language: English
• Published: Heidelberg Springer 01.04.1999; Berlin Springer Nature B.V
• Subjects: Adult; Adverse Drug Reaction Reporting Systems; Aged; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Biological and medical sciences; Cyclooxygenase Inhibitors - adverse effects; Drug toxicity and drugs side effects treatment; Female; Humans; Italy; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Renal Insufficiency - chemically induced; Sulfonamides - adverse effects; Toxicity: urogenital system; Italy; Human; Kidney disease; Prostaglandin-endoperoxide synthase; Urinary system disease; Enzyme; Toxicity; Enzyme inhibitor; Pharmacovigilance; Epidemiology; Non steroidal antiinflammatory agent; Case study; Analgesic; Risk factor; Antipyretic; Secondary effect; Oxidoreductases; Nimesulide
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s002280050610

To analyse from spontaneous reporting data the renal adverse reactions associated with the use of nimesulide. Case reports were obtained from a Northern Italian Regional database (Veneto Pharmacovigilance System), containing all the spontaneous reports filed between 1988 and 1997. The Veneto Region is the principal contributor to the Italian spontaneous reporting system, with an annual report rate of approximately 17 per 100,000 inhabitants. The clinical records of hospitalized patients were also analysed. Of the 120 reports associated with oral nimesulide, 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 hospitalization was required in six cases. Other risk factors were identified in six cases. Together with the new insights into the possible consequences of 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 only extensive epidemiological data can define the real impact of its renal toxicity.