Canada - The manufacturer of olanzapine (Zyprexa®) has circulated information pertaining to cerebrovascular adverse events that have occurred in elderly patients with dementia-related psychosis treated with olanzapine in clinical trials. Olanzapine is not approved for use in elderly patients with dementia-related psychosis.
Recent analysis of some clinical trials in elderly patients with dementia suggests that the use of olanzapine in these patients may be associated with an increased incidence of cerebrovascular adverse events (CVAEs) such as stroke and transient ischemic attacks, including few fatalities.
While elderly patients are at increased risk of CVAEs, the above clinical trial data reflect an increased incidence of such adverse events in patients taking olanzapine compared with placebo-treated dementia patients after adjusting for age, gender, and type of dementia.
Physicians should counsel their patients/ caregivers to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems, so that diagnosis can be made and treatment options considered, including discontinuation, without delay.
The current prescribing information states that olanzapine should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medications).
Reference: Health Canada, http://www.hc-sc.gc.ca10 March 2004.