FDA approves Dificid for treatment of Clostridium difficile-associated diarrhea

FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.

“[Dificid] is a good addition to the armamentarium to fight C. diff,” Perry Hookman, MD, an expert on C. difficile colitis, told Formulary.

The safety and efficacy of Dificid were demonstrated in 2 trials involving 1,164 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 (70% in first trial and 72% in second trial) had a sustained cure 3 weeks after treatment ended versus those patients treated with vancomycin (57% in both trials).

Dificid, a macrolide antibacterial, should be taken 2 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 hand-washing with soap and warm water.