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.
Division of Medicine, Danbury Hospital, CT 06810, USA. paul.iannini@danhosp.org
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P
Iannini
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Mandell
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G
Patou
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Shear
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