September 1, 2004

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.

• Aripiprazole
  http://www.fda.gov/medwatch/SAFETY/2004/abilify.htm
  http://www.fda.gov/medwatch/SAFETY/2004/abilify_pi.pdf
• Clozapine
  http://www.fda.gov/medwatch/SAFETY/2004/Clozaril-deardoc.pdf
  http://www.fda.gov/medwatch/SAFETY/2004/clozaril-PI.pdf
• Olanzapine
  http://www.fda.gov/medwatch/SAFETY/2004/zyprexa.htm
  http://www.fda.gov/medwatch/SAFETY/2004/zyprexa_PI.pdf
• Quetiapine
  http://www.fda.gov/medwatch/SAFETY/2004/seroquel.htm
  http://www.fda.gov/medwatch/SAFETY/2004/Seroquel-lbl.pdf
• Risperidone
  http://www.fda.gov/medwatch/SAFETY/2004/risperdal.htm
  http://www.fda.gov/cder/foi/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf
• Ziprasidone
  http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#geodon
  http://www.fda.gov/medwatch/SAFETY/2004/Geodon083004.pdf