PMID- 12447030
OWN - NLM
STAT- MEDLINE
DCOM- 20030110
LR  - 20181130
IS  - 0890-8567 (Print)
IS  - 0890-8567 (Linking)
VI  - 41
IP  - 12
DP  - 2002 Dec
TI  - Effects of development on olanzapine-associated adverse events.
PG  - 1439-46
AB  - OBJECTIVE: Atypical antipsychotic medications are increasingly prescribed for 
      child and adolescent patients. Relatively little information on adverse events 
      (AEs), specifically in children or adolescents taking atypical antipsychotics, is 
      available. METHOD: The Food and Drug Administration spontaneous AE reporting 
      postmarketing surveillance database was queried for olanzapine until March 31, 
      2000. Patient exposure estimates as of the same date were provided by the 
      manufacturer. AE complaints and exposure estimates were divided by age: children 
      (birth-9 years), adolescents (10-19), and adults (20+). AE complaint risks per 
      10,000 patients exposed were calculated along with risk ratios across age groups 
      and their 95% confidence intervals. RESULTS: Extrapyramidal syndrome complaint 
      risks were similar across development, and tardive dyskinesia complaint risks 
      were comparable in adolescents and adults. Overrepresented AE complaints in 
      children included sedation, weight gain, liver function abnormalities, and 
      tardive dyskinesia. Overrepresented AE complaints in adolescents included 
      sedation, weight gain, liver function abnormalities, and prolactin increase. 
      CONCLUSIONS: Extrapyramidal syndromes may be no more common in children and 
      adolescents with olanzapine than in adults. The frequency of some other AEs may 
      differ across development. Caution is warranted because of the likelihood of 
      reporting bias. Similar analyses should be conducted with other atypical 
      antipsychotics.
FAU - Woods, Scott W
AU  - Woods SW
AD  - Department of Psychiatry, Yale University, New Haven, CT, USA. 
      scott.woods@yale.edu
FAU - Martin, Andres
AU  - Martin A
FAU - Spector, Steven G
AU  - Spector SG
FAU - McGlashan, Thomas H
AU  - McGlashan TH
LA  - eng
GR  - MH01654/MH/NIMH NIH HHS/United States
GR  - MH01792/MH/NIMH NIH HHS/United States
GR  - MH54446/MH/NIMH NIH HHS/United States
GR  - MH61008/MH/NIMH NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 0 (Antipsychotic Agents)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 3G0285N20N (Pirenzepine)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - Age Factors
MH  - Antipsychotic Agents/*adverse effects/therapeutic use
MH  - Basal Ganglia Diseases/chemically induced
MH  - Benzodiazepines
MH  - Child
MH  - Child, Preschool
MH  - Dyskinesia, Drug-Induced/etiology
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Olanzapine
MH  - Pirenzepine/*adverse effects/*analogs & derivatives/therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - United States
EDAT- 2002/11/26 04:00
MHDA- 2003/01/11 04:00
CRDT- 2002/11/26 04:00
PHST- 2002/11/26 04:00 [pubmed]
PHST- 2003/01/11 04:00 [medline]
PHST- 2002/11/26 04:00 [entrez]
AID - S0890-8567(09)60738-3 [pii]
AID - 10.1097/00004583-200212000-00015 [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2002 Dec;41(12):1439-46. doi: 
      10.1097/00004583-200212000-00015.