A post-marketing surveillance of Voltaren tablet as one of the phase IV activities

Abstract

(1) As one of the Phase IV activities, we have collected and analyzed the data on 29, 297 cases treated with Voltaren tablet during past 5 years after marketing. Its efficacy and safety in daily practice were studied.(2) The indications were 40% in musculo-skeleton system, 12.5% in respiratory system, 10% in genitourinary system and 8 % in post-operative and post-tooth extraction pains.(3) About 80% of these cases received 25mg tid regimen with total dosage of 75 mg per day. The duration of treatment was usually one to two weeks occupying 70% of the patients.(4) Clinical efficacy rate revealed 62% in musculo-skeleton system, 82% in respiratory system, 84 % in genitourinary system and 83 % in post-operative and post-tooth extraction pains. Total efficacy rate (markedly effective+effective) was 72 %. This is resembled to the rate of 71 % obtained for its registration. Thus, Voltaren tablet exerted fair clinical effect almost satisfying the needs of clinicians.(5) 3, 770 side effects occurred in 2, 373 cases with an incidence of 8.1%. Those of digestive system including gastric discomfort were predominant with 89 %. Also, systemic symptoms such as edema were rated in 4.3% and skin eruption in 3.9%.