[Severe renal adverse events with arylcarboxylic non-steroidal anti-inflammatory drugs: results of a eight-year French national survey].
The non-steroidal anti-inflammatory drugs (NSAID) especially the arylcarboxylic, are widely prescribed for their different properties. The renal adverse events are rare but often serious. We have reviewed the French experience for the following eight years period: January 1995 to December 2002. Three hundred and nine cases have been reported to the French Pharmacovigilance system during that period including 275 adults, 29 children and 5 new-born babies. In 247 cases (80%), the presentation was an acute renal failure occurring few days after treatment onset but not always of the prerenal type. Overall 34 patients needed one or more dialysis session; the majority recovered either completely or partially, but nevertheless, we had to deplore 5 deaths. These major renal complications were observed with all available NSAID on the French market, including ibuprofen which was often prescribe as pain-reliever. With this data together with international information, the French Drug Agency decided to modify the summary of products characteristics of these NSAID.
Mounier
Geneviève
G
Centre Régional de Pharmacovigilance, Hôpital Bellevue, Saint-Etienne, France. genevieve.mounier@chu-st-etienne.fr
Guy
Claire
C
Berthoux
François
F
Beyens
Marie Noëlle
MN
Ratrema
Martine
M
Ollagnier
Michel
M
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D002648:Child; D003625:Data Collection; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007231:Infant, Newborn; D007674:Kidney Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000473:pathology; D008297:Male
D000894:Anti-Inflammatory Agents, Non-Steroidal