Benoxaprofen: side-effect profile in 300 patients.

Abstract

Out of 300 patients who had taken benoxaprofen for a mean of 6.4 months, 196 (65.3%) reported side effects, resulting in 104 patients (34.6%) having the drug withdrawn. Out of 42 patients aged over 70, 35 (83.3%) had side effects and 29 (69.0%) had the drug withdrawn because of them. cutaneous side effects accounted for 180 (69.5%) of all 259 side effects reported. The commonest cutaneous side effect was photosensitivity, which occurred in 86 patients (28.6%). Photosensitivity, which occurred in half of the patients treated in the summer, resulted in withdrawal of benoxaprofen in 26 (30.2%) of the patients who experienced it. Onycholysis was observed in 38 patients (12.6%) and was frequently unnoticed by patients. The overall incidence of gastric side effects was 12.6% (38 patients), and the figure rose to 40.5% (17 cases) in patients over 70. During treatment with benoxaprofen one patient developed an active duodenal ulcer but no cases of major gastrointestinal haemorrhage occurred. Multiple subepidermal cysts (milia) were observed in 16 patients, who had been treated for a mean of 10.8 months. These findings show that benoxaprofen is a potent phototoxic drug and that the manufacturers' recommended dosage of 600 mg daily is associated with an unacceptable incidence of side effects in the elderly.