Vol.53 No.12 December 2005
Interim report of special surveys on gatifloxacin
QA & RA Division Pharmacovigilance Department, Kyorin Pharmaceutical Co., Ltd.,
2-5 Kanda Surugadai Chiyoda-ku, Tokyo, Japan
Abstract
As the special surveys on gatifloxacin (GFLX), a fluoroquinolone oral antimicrobial agent, we planned to collect 6,000 patients in order to confirm the safety and efficacy and detect the new problems under conditions of actual use of this product. The target sample size in the first survey was 3,000 patients. (The second survey is scheduled to be conducted from 2006 to collect 3,000 patients.) The data collected from 3,384 patients at 607 sites was compiled to prepare an interim report.
The results showed that 56 (1.66%) of 3,369 patients eligible for the safety evaluation had experienced a total of 70 adverse reactions. The commonest ADRs were diarrhoea (8 cases), nausea (6 cases) and exanthem (5 cases). At the same time, the new problems were not detected.
The efficacy rate of GFLX in the 3,212 patients eligible for the efficacy evaluation was 95.3% (observed in 3,060/3,212 patients).
Key word
special survey, gatifloxacin
Received
September 9, 2005
Accepted
November 21, 2005
Jpn. J. Chemother. 53 (12): 748-751, 2005
