PMID- 20156413 OWN - NLM STAT- MEDLINE DCOM- 20100430 LR - 20220408 IS - 1555-2101 (Electronic) IS - 0160-6689 (Linking) VI - 71 IP - 4 DP - 2010 Apr TI - Case reports of postmarketing adverse event experiences with olanzapine intramuscular treatment in patients with agitation. PG - 433-41 LID - 10.4088/JCP.08m04411gry [doi] AB - 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. CI - Copyright 2010 Physicians Postgraduate Press, Inc. FAU - Marder, Stephen R AU - Marder SR AD - Building 210, Room 130, West Los Angeles VA Healthcare Center, 11301 Wilshire Blvd, Los Angeles, CA 90073, USA. marder@UCLA.edu FAU - Sorsaburu, Sebastian AU - Sorsaburu S FAU - Dunayevich, Eduardo AU - Dunayevich E FAU - Karagianis, Jamie L AU - Karagianis JL FAU - Dawe, Ian C AU - Dawe IC FAU - Falk, Deborah M AU - Falk DM FAU - Dellva, Mary Anne AU - Dellva MA FAU - Carlson, Janice L AU - Carlson JL FAU - Cavazzoni, Patrizia A AU - Cavazzoni PA FAU - Baker, Robert W AU - Baker RW LA - eng PT - Case Reports PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20100209 PL - United States TA - J Clin Psychiatry JT - The Journal of clinical psychiatry JID - 7801243 RN - 0 (Antipsychotic Agents) RN - 12794-10-4 (Benzodiazepines) RN - N7U69T4SZR (Olanzapine) SB - IM MH - Adolescent MH - Adult MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Aged MH - Aged, 80 and over MH - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use MH - Benzodiazepines/administration & dosage/*adverse effects/therapeutic use MH - Bipolar Disorder/drug therapy/mortality/psychology MH - Child MH - Databases as Topic/statistics & numerical data MH - Fatal Outcome MH - Female MH - Humans MH - Injections, Intramuscular MH - Male MH - Middle Aged MH - Olanzapine MH - Psychomotor Agitation/*drug therapy MH - Risk Factors MH - Schizophrenia/drug therapy/mortality MH - Schizophrenic Psychology MH - Treatment Outcome EDAT- 2010/02/17 06:00 MHDA- 2010/05/01 06:00 CRDT- 2010/02/17 06:00 PHST- 2008/05/23 00:00 [received] PHST- 2009/01/02 00:00 [accepted] PHST- 2010/02/17 06:00 [entrez] PHST- 2010/02/17 06:00 [pubmed] PHST- 2010/05/01 06:00 [medline] AID - 10.4088/JCP.08m04411gry [doi] PST - ppublish SO - J Clin Psychiatry. 2010 Apr;71(4):433-41. doi: 10.4088/JCP.08m04411gry. Epub 2010 Feb 9.