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 Fre nch drug surveillance system detected 337 cases. Analysis showed that the frequency of cutaneous adverse events was from 0.008 parts per tho usand to 0.023 parts per thousand according to the commercial gel. The sex ratio was well distributed, and the population was young (30-40 y ears) and athletic. Treatment lasted about 7 days, and the appearance of the side-effect was sometimes quite delayed relative to discontinua nce of treatment. Reactions were severe in 40 per cent of cases. The f actors favourable to side-effects were essentially exposure to the sun (one-third of cases) and occlusive dressing. No particular predisposi ng conditions were noted, although 2.6 per cent and 8.5 per cent of ca ses respectively involved earlier sensitization by a topical NSAID. Th e side-effect lasted about 16 days. The course was usually favourable but hospitalization was required in about 10 per cent of cases. Photoa llergological testing indicated photosensitization to ketoprofen. Thes e results led the National Commission of the French drug surveillance system to request a modification in the indications for the prescripti on of the ketoprofen gels.