Case reports of postmarketing adverse event experiences with olanzapine intramuscular treatment in patients with agitation.
ABSTRACT 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.
A Lilly-maintained safety database was searched for all spontaneous adverse events (AEs) reported in temporal association with olanzapine IM treatment.
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.
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.
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ABSTRACT: To review current data about the management of agitated or aggressive patients. Through a search of databases (PubMed and Web of Science), empirical articles and reviews about pharmacological and non-pharmacological interventions for the management of agitation and /or violence were identified. The non-pharmacological management of agitation/aggression encompasses the organization of space and appropriateness of behavior and attitudes of health professionals. The main goal of pharmacological management is rapid tranquilization aimed at reducing symptoms of agitation and aggression, without the induction of deep or prolonged sedation, keeping the patient calm, but completely or partially responsive. Polypharmacy should be avoided, and doses of medications should be as small as possible, adjusted according to clinical need. Intramuscular administration of medication should be considered as a last resort and the options for the use of antipsychotics and benzodiazepines are described and commented. The physical management by means of mechanical restraint may be necessary in violent situations where there is risk to the patient or staff, and must meet strict criteria. Procedures must be carefully implemented to avoid physical and emotional complications for patients and staff.Revista Brasileira de Psiquiatria 10/2010; 32 Suppl 2:S96-103. · 1.20 Impact Factor