Zyprexa

[Olanzapine]

Incidence of Adverse Events in Short-Term, Placebo-Controlled and Combination Trials

The following findings are based on premarketing trials for schizophrenia, bipolar mania, a subsequent trial of patients having various psychiatric symptoms in association with Alzheimer's disease, and premarketing combination trials.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

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Schizophrenia —

Overall, there was no difference in the incidence of discontinuation due to adverse events (5% for olanzapine vs 6% for placebo). However, discontinuations due to increases in SGPT were considered to be drug related (2% for olanzapine vs 0% for placebo) (see PRECAUTIONS).

Bipolar Mania Monotherapy —

Overall, there was no difference in the incidence of discontinuation due to adverse events (2% for olanzapine vs 2% for placebo).

Adverse Events Associated with Discontinuation of Treatment in Short-Term Combination Trials

Bipolar Mania Combination Therapy —

In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse events were 11% for the combination of olanzapine with lithium or valproate compared to 2% for patients who remained on lithium or valproate monotherapy. Discontinuations with the combination of olanzapine and lithium or valproate that occurred in more than 1 patient were: somnolence (3%), weight gain (1%), and peripheral edema (1%).

Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials The most commonly observed adverse events associated with the use of olanzapine (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (olanzapine incidence at least twice that for placebo) were:

There was one adverse event (somnolence) observed at an incidence of 5% or greater among intramuscular olanzapine for injection-treated patients (olanzapine incidence at least twice that for placebo) during the placebo-controlled premarketing studies. The incidence of somnolence during the 24 hour IM treatment period in clinical trials in agitated patients with schizophrenia or bipolar mania was 6% for intramuscular olanzapine for injection and 3% for placebo.

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