Cutaneous adverse events and gemifloxacin: observations from the clinical trial program

J Chemother. 2006 Feb;18(1):3-11. doi: 10.1179/joc.2006.18.1.3.

Abstract

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.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic
  • Exanthema / chemically induced*
  • Fluoroquinolones / adverse effects*
  • Gemifloxacin
  • Humans
  • Naphthyridines / adverse effects*
  • Respiratory Tract Infections / drug therapy*
  • Risk Factors
  • Skin / drug effects*

Substances

  • Fluoroquinolones
  • Naphthyridines
  • Gemifloxacin