This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Biswas, P. N. Articles by Shakir, S. A. W. Search for Related Content PubMed PubMed Citation Articles by Biswas, P. N. Articles by Shakir, S. A. W. Social Bookmarking                         What's this?

The pharmacovigilance of olanzapine: results of a post-marketing surveillance study on 8858 patients in England

Drug Safety Research Unit, Burseldon Hall, Southampton and Faculty of Health and Biological Sciences, University of Southampton, Southampton, UK pipasha.biswas{at}drsu.org

Lynda V. Wilton

Drug Safety Research Unit, Burseldon Hall, Southampton and Faculty of Health and Biological Sciences, University of Southampton, Southampton, UK

Gillian L. Pearce

Shayne Freemantle

Drug Safety Research Unit, Burseldon Hall, Southampton, UK

Saad A. W. Shakir

Drug Safety Research Unit, Burseldon Hall, Southampton and Faculty of Health and Biological Sciences, University of Southampton, Southampton, UK

Olanzapine is an ‘atypical’ antipsychotic indicated for the treatment of schizophrenia. We analysed adverse events (AEs) reported in primary practice in England. Dispensed prescriptions issued between December 1996 and May 1998 provided exposure data. Questionnaires sent to general practitioners provided outcomes. Frequently reported AEs were: drowsiness/sedation (n = 19), extrapyramidal disorder (n = 13) and unspecified side-effects (n = 33). Events with highest incidence density in first month and reason for stopping were: drowsiness/sedation [n = 153, incidence density (ID)1 18.9], weight gain (n = 117, ID1 8.9) and malaise/lassitude (n = 65, ID1 5.2). Extrapyramidal disorders were more common in elderly population (> 70 years, ID1 3.6, risk 26.0 per 1000 patients) compared to < 70 years (ID1 1.1, risk 8.4 per 1000 patients). Serious suspected adverse reactions were neuroleptic malignant syndrome (n = 1) and angioneurotic ooedema (n = 2). There were eight reports of diabetes mellitus assessed as possibly due to olanzapine. Diabetes mellitus was an unlabelled AE and possible signal generated by prescription-event monitoring.

Key Words: adverse drug reaction (ADR) • atypical antipsychotic • extrapyramidal disorder • incidence density (ID) • prescription-event monitoring (PEM)

Journal of Psychopharmacology, Vol. 15, No. 4, 265-271 (2001)
DOI: 10.1177/026988110101500405


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				S. Gentile Antipsychotic Therapy During Early and Late Pregnancy. A Systematic Review Schizophr Bull, September 11, 2008; (2008) sbn107v1. [Abstract] [Full Text] [PDF]

				W S Waring, J Wrate, and D N Bateman Olanzapine overdose is associated with acute muscle toxicity Human and Experimental Toxicology, December 1, 2006; 25(12): 735 - 740. [Abstract] [PDF]

				D. HEALY, M. HARRIS, R. TRANTER, P. GUTTING, R. AUSTIN, G. JONES-EDWARDS, and A. P. ROBERTS Lifetime suicide rates in treated schizophrenia: 1875-1924 and 1994-1998 cohorts compared The British Journal of Psychiatry, March 1, 2006; 188(3): 223 - 228. [Abstract] [Full Text] [PDF]

				C. E Koro, D. O Fedder, G. J L'Italien, S. S Weiss, L. S Magder, J. Kreyenbuhl, D. A Revicki, and R. W Buchanan Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case-control study BMJ, August 3, 2002; 325(7358): 243 - 243. [Abstract] [Full Text] [PDF]