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Individual case safety reports in children in commonly used drug groups - signal detection.
- Source :
-
BMC clinical pharmacology [BMC Clin Pharmacol] 2008 Mar 17; Vol. 8, pp. 1. Date of Electronic Publication: 2008 Mar 17. - Publication Year :
- 2008
-
Abstract
- Background: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children.<br />Methods: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<15 years old) during 2005 were obtained. Descriptive analyses of the adverse drug reactions reported in children were performed.<br />Results: The number of individual case safety reports per million defined daily doses in children varied in the groups of drug between 0 and 24. The largest number was found in the drug group R03DC, the leukotriene receptor antagonist montelukast; the majority of the children being <5 years old and experiencing psychiatric adverse drug reactions.<br />Conclusion: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.
- Subjects :
- Acetates adverse effects
Adolescent
Adverse Drug Reaction Reporting Systems statistics & numerical data
Child
Child, Preschool
Cyclopropanes
Humans
Leukotriene Antagonists adverse effects
Pediatrics
Quinolines adverse effects
Sulfides
Sweden
Adverse Drug Reaction Reporting Systems organization & administration
Drug-Related Side Effects and Adverse Reactions classification
Subjects
Details
- Language :
- English
- ISSN :
- 1472-6904
- Volume :
- 8
- Database :
- MEDLINE
- Journal :
- BMC clinical pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 18366638
- Full Text :
- https://doi.org/10.1186/1472-6904-8-1