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FDA approves fidaxomicin for C. difficile infection
The FDA has approved fidaxomicin twice-daily tablets for the treatment of Clostridium difficile-associated diarrhea in adults.
FDA approval was based upon the safety and efficacy of fidaxomicin (Dificid, Optimer Pharmaceuticals) in two trials consisting of 564 patients with C. difficile infection that compared fidaxomicin with vancomycin.
“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a press release. “[Fidaxomicin] is an effective new treatment option for patients who develop C. difficile-associated diarrhea.”
Common adverse events included nausea, vomiting, headache, abdominal pain and diarrhea.
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