[Results of a French nationwide survey of cutaneous side effects of ketoprofen gel reported between September 1996 and August 2000].

A French nation-wide pharmacovigilance survey of ketoprofen topic collated, from September 1996 to August 2000, 770 cutaneous side-effects. The frequency varies from 0.013@1000 to 0.028@1000 according to the commercial gel. Analysis concerns spontaneous notifications of French nation-wide pharmacovigilance. Sex ratio is well distributed, population is young. Treatment lasted about 12 days, the side-effects appearing after about 13 days, 25 per cent of cases are delayed to discontinuance of treatment, mainly after exposure to sunlight. Co-administered drugs are in most cases systemic or topical NSAIDs and/or fibrates and then increase the seriousness of the iatrogenic pathology. 75 per cent of cutaneous side-effects appear in summer, 50 per cent have been reported as "photosensitivity". Reactions are severe in 30 per cent of the cases. More than 80 per cent of cases present an extension beyond the site of application. The course is usually favourable and neither topical nor systemic corticosteroid treatment influence the duration of evolution. Photopatchtests testing in 23 per cent of cases show evidence of photoallergy to ketoprofen and crossed photoallergy with tiaprofenic acid, fenofibrate, oxybenzone and benzophenone. These results confirm that photoallergy is due to the common benzoylketone structure but not to their arylpropionic function. Some cases of persistent or recurrent photosensitivity must be more explored. The results lead to request a modification of marketing authorizations.