Case reports of postmarketing adverse event experiences with olanzapine intramuscular treatment in patients with agitation
| Autor: | Stephen R. Marder, Eduardo Dunayevich, Sebastian Sorsaburu, Ian C. Dawe, Deborah M. Falk, Mary Anne Dellva, J. Carlson, P. Cavazzoni, Robert W. Baker, Jamie Karagianis |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Olanzapine
Adult Male Pediatrics medicine.medical_specialty Bipolar Disorder Adolescent medicine.drug_class Atypical antipsychotic Injections Intramuscular Benzodiazepines Fatal Outcome Risk Factors medicine Adverse Drug Reaction Reporting Systems Humans Bipolar disorder Adverse effect Child Depression (differential diagnoses) Psychomotor Agitation Aged Aged 80 and over business.industry Dopamine antagonist Middle Aged medicine.disease Psychiatry and Mental health Treatment Outcome Databases as Topic Schizophrenia Concomitant Anesthesia Female Schizophrenic Psychology business medicine.drug Antipsychotic Agents |
| Zdroj: | The Journal of clinical psychiatry. 71(4) |
| ISSN: | 1555-2101 |
| Popis: | Objective Agitation is a medical emergency with increased risk for poor outcome. Successful treatment often requires intramuscular (IM) psychotropics. Safety data from the first 21 months of olanzapine IM, approved in the United States for the treatment of agitation associated with schizophrenia and bipolar disorder, are presented. Method A Lilly-maintained safety database was searched for all spontaneous adverse events (AEs) reported in temporal association with olanzapine IM treatment. Results The estimated worldwide patient exposure to olanzapine IM from January 1, 2004, through September 30, 2005, was 539,000; 160 cases containing AEs were reported from patients with schizophrenia (30%), bipolar disorder (21%), unspecified psychosis (10%), dementia (8%), and depression (5%). Many reported concomitant treatment with benzodiazepines (39%) or other antipsychotics (54%). The most frequently reported events involved the following organ systems: central nervous (21%), cardiac (12%), respiratory (6%), vascular (6%), and psychiatric (5%). Eighty-three cases were considered serious, including 29 fatalities. In these fatalities, concomitant benzodiazepines or other antipsychotics were reported in 66% and 76% of cases, respectively. The most frequently reported events in the fatal cases involved the following organ systems: cardiovascular (41%), respiratory (21%), general (17%), and central nervous (10%). The majority of fatal cases (76%) included comorbid conditions and potentially clinically significant risk factors for AEs. Conclusions Clinicians should use care when treating agitated patients, especially when they present with concurrent medical conditions and are treated with multiple medications, which may increase the risk of poor or even fatal outcomes. Clinicians should use caution when using olanzapine IM and parenteral benzodiazepines simultaneously. |
| Databáze: | OpenAIRE |
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