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 typically less than 1.5%, a rate similar to that for other fluoroquinolones and lower than other frequently used community antimicrobials. The rash associated with gemifloxacin has not been linked with cross or subclinical-sensitization nor any systemic manifestations such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. This review describes the extensive studies conducted to support the use of this agent for short durations in community infections.
Iannini
P
P
Division of Medicine, Danbury Hospital, CT 06810, USA. paul.iannini@danhosp.org
Mandell
L
L
Patou
G
G
Shear
N
N
D002986:Clinical Trials as Topic; D005076:Exanthema / Q000139:chemically induced*; D024841:Fluoroquinolones / Q000009:adverse effects*; D000077735:Gemifloxacin; D006801:Humans; D009287:Naphthyridines / Q000009:adverse effects*; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012307:Risk Factors; D012867:Skin / Q000187:drug effects*
D024841:Fluoroquinolones; D009287:Naphthyridines; D000077735:Gemifloxacin