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
- Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns (Feb 2011)
- FDA Information for Healthcare Professionals: Atypical Antipsychotics
- FDA Safety Alert: Use in Adolescents (Jan 2010)
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information