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Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome has been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.
Clinical manifestations of NMS or the presence of high fever without clinical manifestations of NMS require discontinuation of all antipsychotic drugs, including olanzapine.
Safety Experience in Elderly Patients with Dementia-Related Psychosis: After analysis of placebo-controlled studies revealed an increased risk in stroke and a twofold increase in all-cause mortality. It was considered that the risk may not be confined to use dementia and should be considered relevant to any patient with a history of stroke or transient ischemic attack or other risk factors for cerebrovascular disease, including hypertension, diabetes, current smoking or atrial fibrillation.
