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Clozapine-associated diabetes.

E Koller1, B Schneider, K Bennett

  • 1Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA.

The American Journal of Medicine
|December 19, 2001
PubMed
Summary
This summary is machine-generated.

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Clozapine, an antipsychotic, is linked to new-onset diabetes and worsening of existing diabetes. Many cases occurred within six months of starting clozapine, with some improving after drug discontinuation.

Area of Science:

  • Pharmacovigilance
  • Endocrinology
  • Psychiatry

Background:

  • Clozapine is a widely used antipsychotic medication.
  • Reports of diabetes mellitus associated with clozapine therapy have increased.
  • The precise risks and characteristics of clozapine-associated diabetes remain unclear.

Purpose of the Study:

  • To investigate the risk and characteristics of diabetes mellitus in patients treated with clozapine.
  • To analyze spontaneous adverse event reports of hyperglycemia associated with clozapine.

Main Methods:

  • A descriptive epidemiologic study was conducted.
  • Data were collected from the Food and Drug Administration MedWatch surveillance program (1990-2001) and pooled with published cases.
  • Key parameters included diabetes documentation, severity, onset, patient demographics, and response to drug withdrawal.

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Main Results:

  • 384 reports of hyperglycemia were identified, with 242 new-onset diabetes cases and 54 exacerbations of pre-existing diabetes.
  • Most cases occurred within 6 months of clozapine initiation, with a mean patient age of 40 years.
  • Severe outcomes included 80 cases of metabolic acidosis/ketosis and 25 deaths; 46 patients improved after clozapine discontinuation or dose reduction.

Conclusions:

  • A causal relationship between clozapine and diabetes mellitus is suggested.
  • The temporal association, patient demographics, and reversibility upon drug withdrawal support this link.
  • Clozapine-associated diabetes can range from mild glucose intolerance to severe diabetic ketoacidosis or hyperosmolar coma.