The U.S. Food and Drug Administration recently approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
The safety and efficacy of Dificid has been demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.
Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.
To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.
People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htm
The safety and efficacy of Dificid has been demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.
Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.
To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.
People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htm
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