PMID- 11769820
OWN - NLM
STAT- MEDLINE
DCOM- 20020529
LR  - 20181130
IS  - 0269-8811 (Print)
IS  - 0269-8811 (Linking)
VI  - 15
IP  - 4
DP  - 2001 Dec
TI  - The pharmacovigilance of olanzapine: results of a post-marketing surveillance 
      study on 8858 patients in England.
PG  - 265-71
AB  - 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 1,000 
      patients) compared to < 70 years (ID1 1.1, risk 8.4 per 1,000 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.
FAU - Biswasl, P N
AU  - Biswasl PN
AD  - Drug Safety Research Unit, Faculty of Health and Biological Sciences, University 
      of Southampton, UK. pipasha.biswas@dsru.org
FAU - Wilton, L V
AU  - Wilton LV
FAU - Pearcel, G L
AU  - Pearcel GL
FAU - Freemantle, S
AU  - Freemantle S
FAU - Shakir, S A
AU  - Shakir SA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Antipsychotic Agents)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 3G0285N20N (Pirenzepine)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antipsychotic Agents/*adverse effects/therapeutic use
MH  - Benzodiazepines
MH  - Child
MH  - Cohort Studies
MH  - England
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Olanzapine
MH  - Pirenzepine/*adverse effects/*analogs & derivatives/therapeutic use
MH  - Pregnancy
MH  - Product Surveillance, Postmarketing
MH  - Schizophrenia/drug therapy/mortality
MH  - Sex Factors
MH  - Surveys and Questionnaires
EDAT- 2002/01/05 10:00
MHDA- 2002/05/30 10:01
CRDT- 2002/01/05 10:00
PHST- 2002/01/05 10:00 [pubmed]
PHST- 2002/05/30 10:01 [medline]
PHST- 2002/01/05 10:00 [entrez]
AID - 10.1177/026988110101500405 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2001 Dec;15(4):265-71. doi: 10.1177/026988110101500405.