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U.S. Department of Health and Human Services

Safety

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Cleocin HCL (clindamycin hydrochloride) capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009 and June 2014

 

June 2014

Summary View

WARNINGS

Severe Skin Reactions

  • Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported. In case of such an event, treatment should be permanently discontinued.

  • A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

  • Pregnancy:  In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities.
  • Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

ADVERSE REACTIONS

Hypersensitivity Reactions

  • Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported. Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, and anaphylactoid reactions have also been reported.

 Immune system

  • Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

 

November 2009

 

Summary View

 

 

BOXED WARNING

Clostridium difficile
  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin HCL and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.difficle
  • 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. 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 over two months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treamtment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

WARNING

  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin HCL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Clostridium difficile .
  • C. Clostridium difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. Clostridium difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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 over 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.

PRECAUTIONS

  • Prescribing CLEOCIN HCl in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.