A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.
OBJECTIVE
To explore the clinical characteristics of hyperglycemia in patients treated with quetiapine.


METHODS
A pharmacovigilance survey of spontaneously reported adverse events in quetiapine-treated patients was conducted using reports from the U.S. Food and Drug Administration MedWatch program (January 1, 1997, through July 31, 2002) and published cases using the search terms hyperglycemia, diabetes, acidosis, ketosis, and ketoacidosis.


RESULTS
We identified 46 reports of quetiapine-associated hyperglycemia or diabetes and 9 additional reports of acidosis that occurred in the absence of hyperglycemia and were excluded from the immediate analyses. Of the reports of quetiapine-associated hyperglycemia, 34 patients had newly diagnosed hyperglycemia, 8 had exacerbation of preexisting diabetes mellitus, and 4 could not be classified. The mean +/- SD age was 35.3 +/- 16.2 years (range, 5-76 years). New-onset patients (aged 31.2 +/- 14.8 years) tended to be younger than those with preexisting diabetes (43.5 +/- 16.4 years, p = .08). The overall male:female ratio was 1.9. Most cases appeared within 6 months of quetiapine initiation. The severity of cases ranged from mild glucose intolerance to diabetic ketoacidosis or hyperosmolar coma. There were 21 cases of ketoacidosis or ketosis. There were 11 deaths.


CONCLUSIONS
Atypical antipsychotic use may unmask or precipitate hyperglycemia.
An additional 23 cases were identified since August 1, 2002, the end of the first survey, by extending the search through November 30, 2003, bringing the total to 69.
Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Review, US Food and Drug Administration, Rockville, MD, USA.
Elizabeth A
EA
Koller
Jena
J
Weber
P Murali
PM
Doraiswamy
Bruce S
BS
Schneider
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D003922:Diabetes Mellitus, Type 1 / Q000139:chemically induced* / Q000453:epidemiology; D016883:Diabetic Ketoacidosis / Q000139:chemically induced / Q000453:epidemiology; D003987:Dibenzothiazepines / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced* / Q000453:epidemiology; D006944:Hyperglycemic Hyperosmolar Nonketotic Coma / Q000139:chemically induced / Q000453:epidemiology; D016239:MEDLINE; D008297:Male; D001523:Mental Disorders / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D008875:Middle Aged; D017891:Pharmacoepidemiology; D000069348:Quetiapine Fumarate; D012559:Schizophrenia / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology; D017678:Sex Distribution; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000639:trends
D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate