title: Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections.
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.
authors: Department of Infectious Diseases and Microbiology, Maisonneuve-Rosemont Hospital, Faculty of Medicine, University of Montreal, Quebec, Canada. weisscan@aol.com
authors: Karl
authors: K
authors: Weiss
authors: Robin L
authors: RL
authors: Allgren
authors: Sarah
authors: S
authors: Sellers
mesh_terms: D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000818:Animals; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D016360:Clostridioides difficile / Q000472:pathogenicity*; D003015:Clostridium Infections / Q000188:drug therapy* / Q000382:microbiology; D003967:Diarrhea / Q000382:microbiology; D004285:Dogs; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D000077732:Fidaxomicin; D006801:Humans; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use*
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D014640:Vancomycin; D000077732:Fidaxomicin