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Side Effects & Drug Interactions
ADVERSE REACTIONS
The information below is derived from a clinical trial database for olanzapine consisting of 8661 patients with approximately 4165 patient-years of exposure. This database includes: (1) 2500 patients who participated in multiple-dose premarketing trials in schizophrenia and Alzheimer's disease representing approximately 1122 patient-years of exposure as of February 14, 1995; Text Continues Below
(2) 182 patients who participated in premarketing bipolar mania trials representing approximately 66 patient-years of exposure; (3) 191 patients who participated in a trial of patients having various psychiatric symptoms in association with Alzheimer's disease representing approximately 29 patient-years of exposure; and (4) 5788 patients from 88 additional clinical trials as of December 31, 2001. In addition, information from the premarketing 6-week clinical study database for olanzapine in combination with lithium or valproate, consisting of 224 patients who participated in bipolar mania trials with approximately 22 patient-years of exposure, is included below. The conditions and duration of treatment with olanzapine varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analytes, ECGs, chest x-rays, and results of ophthalmologic examinations. Certain portions of the discussion below relating to objective or numeric safety parameters, namely, dose-dependent adverse events, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia and have not been duplicated for bipolar mania. However, this information is also generally applicable to bipolar mania and agitation. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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