Individual case safety reports in children in commonly used drug groups - signal detection.
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.


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.


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.


CONCLUSIONS
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.
Brunlöf
Gertrud
G
Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45 Göteborg, Sweden. susanna.wallerstedt@pharm.gu.se
Tukukino
Carina
C
Wallerstedt
Susanna M
SM
D000085:Acetates / Q000009:adverse effects; D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration* / Q000706:statistics & numerical data; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects; D010372:Pediatrics; D011804:Quinolines / Q000009:adverse effects; D013440:Sulfides; D013548:Sweden
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast