Safety evaluation of gatifloxacin, a new fluoroquinolone

Abstract

We conducted clinical studies of gatifloxacin (GFLX) and published results of individual studies in earlier issues of this journal. Recollation of case reports with source data has shown the necessity of some corrections in published papers. We therefore report collectively results based on our reanalysis of all safety data involving the2, 889patients treated.
1. Adverse Drug Reactions
Adverse drug reactions were evaluated in 2, 727 qualifed patients, and their incidence was 4.5%(122/2, 727).No large differences were seen in the incidence of reactions among medical fields and ageclassified strata. No increase in incidence was noted in the elderly. Adverse drug reactions were all mild or moderate and none serious. Specifically, 70%of all adverse drug reactions were gastrointestinal disorders with an incidence of 4.1%(112/2, 727), followed by central and peripheral nervous disorders with an incidence of 1.0%(26/2, 727).Major events include diarrhea (1.0%;26/2, 727), nausea (1.0%;26/2, 727), vomiting (0.4%;12/2, 727), rash (0.3%);9/2, 727), and dizziness (0.3%;8/2, 727). Photosensitive reaction, a common but rare symptom reported among the existing fluoroquinolones, was not seen in any patient in any study with GFLX.
2. Abnormal Laboratory Findings
Abnormal laboratory findings were evaluated in 2, 160qualified patients, and their incidence was 6.3%(136/2, 160).Major findings were increases in S-GPT (2.8%;59/2, 127), S-GOT (1.9%;41/2, 130), and eosinophilia (1.1%;19/1, 753).
Reanalysis of all data confirmed that the present conclusion in safety aspects of GFLX is consistent with results published. The incidence of adverse drug reactions and abnormal laboratory findings noted with GFLX in all studies are similar to those of existing fluoroquinolones. No event was serious or clinically significant.