Dificid Expanded Approval for Pediatric Use

FDA has approved Merck’s Dificid (fidaxomicin) oral suspension and tablets for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial was previously indicated in adults for treating Clostridium difficile-associated diarrhea.

Difficile is a bacterium that causes diarrhea and colitis, which can be life-threatening and is easily spread between patients. The infection often occurs after a person takes antibacterial drugs or after an extended stay in a hospital, where it could be transmitted from infected patients, an agency release says. “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,” it says.