A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.

Publisher: Physicians Postgraduate Press Country of Publication: United States NLM ID: 7801243 Publication Model: Print Cited Medium: Print ISSN: 0160-6689 (Print) Linking ISSN: 01606689 NLM ISO Abbreviation: J Clin Psychiatry Subsets: MEDLINE

Original Publication: Memphis, Tenn., Physicians Postgraduate Press.

Antipsychotic Agents/*adverse effects ; Diabetes Mellitus, Type 1/*chemically induced ; Dibenzothiazepines/*adverse effects ; Hyperglycemia/*chemically induced ; Mental Disorders/*drug therapy; Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems/trends ; Aged ; Antipsychotic Agents/therapeutic use ; Child ; Child, Preschool ; Comorbidity ; Diabetes Mellitus, Type 1/epidemiology ; Diabetic Ketoacidosis/chemically induced ; Diabetic Ketoacidosis/epidemiology ; Dibenzothiazepines/therapeutic use ; Female ; Humans ; Hyperglycemia/epidemiology ; Hyperglycemic Hyperosmolar Nonketotic Coma/chemically induced ; Hyperglycemic Hyperosmolar Nonketotic Coma/epidemiology ; MEDLINE ; Male ; Mental Disorders/blood ; Mental Disorders/epidemiology ; Middle Aged ; Pharmacoepidemiology ; Quetiapine Fumarate ; Schizophrenia/blood ; Schizophrenia/drug therapy ; Schizophrenia/epidemiology ; Sex Distribution ; United States/epidemiology ; United States Food and Drug Administration/trends

Objective: To explore the clinical characteristics of hyperglycemia in patients treated with quetiapine.
Method: 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.
Conclusion: Atypical antipsychotic use may unmask or precipitate hyperglycemia.
Update: 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.

0 (Antipsychotic Agents)
0 (Dibenzothiazepines)
2S3PL1B6UJ (Quetiapine Fumarate)

Date Created: 20040805 Date Completed: 20040831 Latest Revision: 20211018

20240628

10.4088/jcp.v65n0619

15291665