Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Cleocin HCL (clindamycin hydrochloride) capsules, an antibiotic used to treat serious infections caused by bacteria, has received a new black box warning about the risk of Clostridium difficile (C. difficile) associated diarrhea (CDAD) that may range in severity from mild diarrhea to fatal colitis, according to the Food and Drug Administration (FDA). CDAD has been reported with use of nearly all antibacterial agents, including Cleocin HCL. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Clostridium difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. As a result, CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur as much as two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. Clostridium difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. Clostridium difficile, and surgical evaluation should be instituted as clinically indicated.

Any adverse events with this or any other medication should be reported to the FDA’s MedWatch reporting system at www.fda.gov/medwatch.

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