The U.S. Food and Drug Administration (FDA) approved Dificid (fidaxomicin) tablets and oral suspension for use in pediatric patients 6 months of age and older for the treatment of Clostridioides difficile (C. difficile) associated diarrhea (CDAD). This approval provides an additional safe and effective treatment option as well as a new formulation for this vulnerable pediatric patient population. Dificid tablets were previously approved for the treatment of CDAD in adults 18 years and older.
C. difficile is a bacterium that causes diarrhea and colitis (an inflammation of the colon), which can be life-threatening. According to the Centers for Disease Control and Prevention (CDC), infection with C. difficile is estimated to cause almost half a million illnesses in the United States each year, and about 1 in 5 patients who get C. difficile will get it again. C. difficile is contagious and can easily be spread between patients. The infection most commonly occurs after a person takes antibacterial drugs or after a person has had an extended stay in a hospital, where it could be transmitted from infected patients. The CDC classified C. difficile as an urgent threat in their 2019 annual Antibiotic Resistant Threats Report.
The most common adverse reactions observed in pediatric patients treated with Dificid included vomiting, diarrhea, abdominal pain, constipation, fever and increased aminotransferases. To reduce the development of drug resistant bacteria and maintain the effectiveness of Dificid and other antibacterial drugs, Dificid should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
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