Antibiotics Linked to Risk for Posttherapy Clostridium difficile–Associated Diarrhea
The FDA approved in February safety labeling revisions for antimicrobial drugs to warn of the risk for Clostridium difficile–associated diarrhea (CDAD).
Updated product monographs include those for clindamycin injection (Cleocin; Pfizer, Inc); lincomycin injection (Lincocin; Pfizer, Inc); cefotaxime injection (Claforan; sanofi-aventis US), erythromycin delayed-release capsules (Eryc; Warner Chilcott US, Inc); erythromycin lactobionate injection (Erythrocin Lactiobionate; Hospira, Inc); doxycycline hyclate capsules (Doryx; Warner Chilcott); doxycycline hyclate film-coated tablets (Vibra-Tabs; Pfizer); and doxycycline hyclate capsules, doxycycline calcium syrup, and doxycycline monohydrate oral suspension (Vibramycin; Pfizer).
Use of these agents can alter the colon's normal flora, leading to overgrowth of C difficile and subsequent release of toxins A and B that contribute to the development of CDAD. Nearly all antibiotics have been implicated in CDAD, which may range in severity from mild diarrhea to fatal colitis.
Because hypertoxin-producing strains of C difficile can be refractory to antimicrobial therapy, they are associated with increased morbidity and mortality and may require colectomy. The FDA advises that CDAD be considered in all patients who present with diarrhea after antibiotic use. Careful examination of medical history is required because of the potential for late-onset disease; cases of CDAD have been reported more than 2 months after completion of an antimicrobial course of therapy.
The FDA notes that current antibiotic therapy for the primary infection may need to be discontinued in patients with known or suspected CDAD. Appropriate fluid and electrolyte management, protein supplementation, antibiotic therapy for C difficile, and surgical evaluation also may be required.
Clindamycin is a lincosamide antibiotic indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and those caused by susceptible strains of streptococci, pneumococci, and staphylococci. Also a lincosamide antibiotic, lincomycin is indicated for the treatment of serious infections caused by susceptible strains of streptococci, pneumococci, and staphylococci.
Cefotaxime is a third-generation cephalosporin antibiotic with a broad spectrum of activity against gram-positive and gram-negative bacteria, doxycycline is a broad-spectrum tetracycline antibiotic, and erythromycin is a macrolide antibiotic with an antimicrobial spectrum similar to or slightly wider vs penicillin.
Serevent Prescribing Information
Letairis Prescribing Information
Cleocin Prescribing Information
Lincocin Prescribing Information
Claforan Prescribing Information
Erythrocin Prescribing Information
Vibramycin Prescribing Information