Cutaneous Adverse Events and Gemifloxacin: Observations from the Clinical Trial Program

Cutaneous adverse events are seen with many antimicrobials. A signal was observed with gemifloxacin in the original clinical research program, however subsequent studies and analysis demonstrated a mild-moderate self-limited macular-papular rash seen most frequently when the duration of exposure was beyond 7 days, a non-approved duration. Following administration for 5 days for community-acquired respiratory tract infections the rash rate is …