Objective: To assess the incidence of adverse drug reactions (ADRs) in the paediatric population and the safety alerts concerning children and adolescents issued by international drug regulatory agencies since 2001.
Methods: A bibliographic search was performed in the Medline and Embase databases for prospective studies published between January 2001 and December 2007 evaluating the ADR incidence in the paediatric population. Data were analysed by a random effect model. Moreover, the websites of 9 international drug regulatory agencies were searched with the aim to collect information on safety alerts concerning the paediatric population.
Results: A total of 8 prospective studies were evaluated, six of which concerned the ADR incidence in hospitalised children. The overall incidence of ADRs was 10.9% (95%CI 4.8-17.0) in hospitalised children and 1.0% (95%CI 0.3-1.7) in outpatient children. The rate of hospital admission due to ADRs was 1.8% (95%CI 0.4-3.2). The skin and gastrointestinal system were the organs most commonly affected and antibiotics were the drugs most commonly associated with ADRs.
Safety alerts in the paediatric population were retrieved for 28 drugs, 5 of which were psychotropic drugs and most of which were issued by the Food and Drug Administration (20 drugs).
For 12 drugs, warnings were published in the 2006-2007 period. Only for antidepressants were alerts issued by all the drug regulatory agencies.
Conclusions: To ensure safe and effective medicines for children, efforts are needed at different levels (governments, drug regulatory agencies, pharmaceutical industries, health care professionals, and parents). Collaborative regulatory initiatives, as the use of common warnings, can also contribute to a more rational use of drugs for children.
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