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Oral and Injectable Formulations

Increased Mortality in Elderly Patients with Dementia Related Psychosis

  • Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
  • Analyses of seventeen placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipyschotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group.
  • Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
  • Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
  • The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
  • This drug is not approved for the treatment of patients with dementia-related psychosis (See WARNINGS in package insert).

Injectable Formulation Only

Post Injection Delirium/Sedation Syndrome

  • Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine.
  • Olanzapine injection must be administered in a registered health care facility with ready access to emergency response services.
  • After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours.
  • Because of this risk, olanzapine injectable is available only through a restricted distribution program called Zyprexa Relprevv Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment.

FDA and Industry Communications


Approved Risk Evaluation and Mitigation Strategies (REMS)

Zyprexa Relprevv (Olanzapine) Kit

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Additional Information

Updated January 2018