Nimesulide and renal impairment.
OBJECTIVE
To analyse from spontaneous reporting data the renal adverse reactions associated with the use of nimesulide.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Leone
R
R
Clinical Pharmacology Unit, Institute of Pharmacology, Policlinico B.go Roma, University of Verona, Italy. leone@farma.univr.it
Conforti
A
A
Ghiotto
E
E
Moretti
U
U
Valvo
E
E
Velo
G P
GP
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D051437:Renal Insufficiency / Q000139:chemically induced*; D013449:Sulfonamides / Q000009:adverse effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D013449:Sulfonamides; C012655:nimesulide