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Clin Infect Dis. 2012 Aug;55 Suppl 2:S110-5. doi: 10.1093/cid/cis390.

Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections.

Author information

  • 1Department of Infectious Diseases and Microbiology, Maisonneuve-Rosemont Hospital, Faculty of Medicine, University of Montreal, Quebec, Canada. weisscan@aol.com

Abstract

Fidaxomicin is a novel macrocyclic antibiotic recently approved by the US Food and Drug Administration for the treatment of Clostridium difficile-associated diarrhea in adults. We reviewed safety data from nonclinical studies and clinical trials (phases 1, 2A, and 3) with fidaxomicin. In nonclinical studies, fidaxomicin was administered orally at approximately 1 g/kg/d to dogs for up to 3 months with no significant target-organ toxicities observed. A total of 728 adults have received oral fidaxomicin in clinical trials to date: 116 healthy volunteers and 612 patients with C. difficile infection. In phase 3 clinical trials, fidaxomicin was well tolerated, with a safety profile comparable with oral vancomycin. There were no differences in the incidence of death or serious adverse events between the 2 drugs. Fidaxomicin appears to be well tolerated. Continued monitoring of adverse events in the postmarketing setting will provide additional information about the full safety profile of fidaxomicin.

PMID:
22752858
[PubMed - indexed for MEDLINE]
PMCID:
PMC3388027
Free PMC Article
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