Jane S. Ricciuti, RPh, MS

Disclosures

June 03, 2004

In This Article

Antipsychotic Agents

Abilify
(aripiprazole) Tablets

Manufacturer: Otsuka

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 04/08/04)

New Warnings: This supplemental NDA is for revised labeling regarding hyperglycemia occurrence in patients taking Abilify (aripiprazole):

  • Hyperglycemia and Diabetes Mellitus

    • Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia in patients treated with Abilify. Although fewer patients have been treated with Abilify, it is not known whether this more limited experience is the sole reason for the paucity of such reports. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiologic studies that did not include Abilify suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics included in these studies. Because Abilify was not marketed at the time these studies were performed, it is not known whether Abilify is associated with this increased risk. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.

    • Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (eg, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.

Abilify (Aripiprazole) Tablets Letter

Abilify (Aripiprazole) Tablets

Zyprexa (olanzapine) Injection

Manufacturer: Lilly

Drug Approval Classification: Original New Drug Application (Approval Date: 03/29/04)

Indication: This NDA provides for the use of Zyprexa IntraMuscular (olanzapine) for Injection for the treatment of agitation associated with schizophrenia and bipolar I mania.

Dosing: The recommended dose in patients with agitation associated with schizophrenia or bipolar I mania is 10 mg. A lower dose of 5 or 7.5 mg may be considered. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been evaluated in controlled clinical trials.

Pharmacokinetics: Olanzapine intramuscular injection is absorbed rapidly, and peak plasma concentrations occur within 15 to 45 minutes. In healthy volunteers, a 5-mg dose of intramuscular olanzapine for injection produces a maximum plasma concentration approximately 5 times higher than the maximum plasma concentration produced by a 5-mg dose of oral olanzapine.

Zyprexa (olanzapine) Injection Labeling

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