Gemifloxacin

FDA

• Currently not available in the U.S. due to legal dispute related to license to manufacture and distribute (FDA notice-Gemifloxacin )
• Community acquired pneumonia (CAP) caused by S. pneumoniae (including multi-drug resistant strains), H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, or K. pneumoniae
• Acute bacterial exacerbation of chronic bronchitis (AECB) caused by S. pneumoniae, H. influenzae, H. parainfluenzae, or M. catarrhalis
  • Use for AECB should be avoided due recent FDA warning (Black Box warning) regarding serious and potentially permanent side effects (tendonitis and tendon rupture, peripheral neuropathy, and CNS side effects). See FDA safety warning regarding fluoroquinolone use.