[Cutaneous side effects of ketoprofen gels: results of a study based on 337 cases]

Ketoprofen gels, since their introduction on the French market (1989), have been responsible for various cutaneous side-effects (essentially photosensitization and contact eczemas). A study conducted by the French drug surveillance system detected 337 cases. Analysis showed that the frequency of cutaneous adverse events was from 0.008/1000 to 0.023/1000 according to the commercial gel. The sex ratio was well distributed, and the population was young (30-40 years) and athletic. Treatment lasted about 7 days, and the appearance of the side-effect was sometimes quite delayed relative to discontinuance of treatment. Reactions were severe in 40 per cent of cases. The factors favourable to side-effects were essentially exposure to the sun (one-third of cases) and occlusive dressing. No particular predisposing conditions were noted, although 2.6 per cent and 8.5 per cent of cases respectively involved earlier sensitization by a topical NSAID. The side-effect lasted about 16 days. The course was usually favourable but hospitalization was required in about 10 per cent of cases. Photoallergological testing indicated photosensitization to ketoprofen. These results led the National Commission of the French drug surveillance system to request a modification in the indications for the prescription of the ketoprofen gels.