We conducted a drug use evaluation study on Carbenin® according to the “Guidelines on the Testing Methods for Evaluating the Use of New Drug Products, etc. in Applying for Drug Reexamination ”, based on the Revised GPMSP issued April 1994. Our study was conducted using the repeated testing method under actual treatment conditions. This drug use evaluation was made over a period of about 3 years lasting until March 1997, including the pilot study that started in February 1994. Among the 17, 872 cases reports collected, we examined the 17, 748 cases eligible for safety analysis, excluding the 124 cases disqualified due to reasons such as their being recorded outside the designated time period. The resulting ADR (including abnormal laboratory values) incidence was 9. 34%(1, 658 out of 17, 748 cases), showing no elevation tendency compared to the 16. 97%(443 out of 2, 611 cases) at the time of approval. Also, no significant deviation was noted in the schematic proportions. Though both safety and efficacy were examined in our study, we are reporting only the test results on safety because this drug is presently under reexamination (October 1, 1993-September 30, 1999).
