Safety Labels To Carry Risk Warnings About Clostridium difficile

Medscape, the online medical newsletter from WebMD, is reporting on recent safety labeling changes to give the public more information about Clostridium difficile.

The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of an interaction between amoxicillin and certain urine glucose tests, and to include patient information regarding the risk for the development of Clostridium difficile–associated diarrhea more than 2 months after completion of treatment with a prepackaged regimen of lansoprazole, amoxicillin, and clarithromycin tablets,” its reports.

“The agency also warned that amoxicillin, clarithromycin, and other antibiotics have been linked to a risk for Clostridium difficile–associated diarrhea (CDAD) that may range in severity from mild diarrhea to fatal colitis and occur more than 2 months after treatment is completed. Because hypertoxin-producing strains of C difficile can be refractory to antimicrobial therapy, they are associated with increased morbidity and  mortality rates and may require colectomy."

Read the rest in Medscape.