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Atypical antipsychotics and hyperglycemia ¿ Aripiprazole (Abilify) clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon)

October 19, 2009

Hyperglycemia, including ketoacidosis, hyperosmolar coma, or death can occur in patients treated with atypical antipsychotics including aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon). The product labeling for aripiprazole, clozapine, olanzapine, risperidone, quetiapine, and ziprasidone were recently revised to include this information. All atypical antipsychotics may cause this effect.

Monitor any patient treated with an atypical antipsychotic for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Additionally, monitor patients with concomitant diabetes being treated with the atypical antipsychotics for worsening glucose control. Perform fasting blood glucose testing on any patient who develops symptoms of hyperglycemia during treatment with these agents.

Further details concerning these product labeling changes can be found at the FDA MedWatch web site at the following links:

Aripiprazole

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153025.htm
• Dear Healthcare Professional letter:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165253.htm
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21436slr006_abilify_lbl.pdf

Clozapine

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154110.htm
• Dear Healthcare Professional Letter:
  http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM166139.pdf
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf

Olanzapine

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166542.htm
• Dear Healthcare Professional Letter:
  http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM166545.pdf
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf

Quetiapine

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155495.htm
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf

Risperidone

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166517.htm
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf

Ziprasidone

• MedWatch Alert:
  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154977.htm
• Dear Healthcare Professional Letter:
  http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM166433.pdf
• Revised Product Label:
  http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf

Updated
October 19, 2009; September 1, 2004; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.