%0 Journal Article
%T Individual case safety reports in children in commonly used drug groups ¨C signal detection
%A Gertrud Brunl£¿f
%A Carina Tukukino
%A Susanna M Wallerstedt
%J BMC Pharmacology and Toxicology
%D 2008
%I BioMed Central
%R 10.1186/1472-6904-8-1
%X 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.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.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.Adverse drug reactions (ADRs) are a major health care problem. ADRs cause hospital care in both adults [1-3] and children [4]. Moreover, drug-related deaths have been reported for children [5,6]. Consequently, a risk-benefit analysis of drug treatment is essential in most patient consultations including paediatric patients. This implies access of adequate knowledge on both these parameters. Due to few paediatric drug safety studies, knowledge on risks in children is limited. At registration, little information on ADRs in children is available since many drugs have not been tested in children [7]. Off-label use of drugs in children results in questions to drug information centres [8] and has been reported to be extensive [9-11], reported to result in an increased risk of ADRs [9]. Risk-benefit analyses of drugs for children are therefore dependent on observations of ADRs and effects from clinical use.Spontaneous reporting of ADRs is an important method for detection of signals, which is one aim of pharmacovigilance. An ADR signal is defined as a possible relationship between an adverse event and a drug, the r
%U http://www.biomedcentral.com/1472-6904/8/1