1 Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, Københavns Universitet2 Faculty of Health Sciences, Institute of Public Health, University of Southern Denmark, J.B. Winsløws Vej 19, 5000, Odense C, Denmark, firstname.lastname@example.org Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, Københavns Universitet
Background Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children. Objective To characterize paediatric ADRs reported for asthma medications licensed for paediatric use. Setting Spontaneous ADR reports located in the European ADR database, EudraVigilance. Method ADRs reported for asthma medications licensed for paediatric use from 2007 to 2011 were analysed. The included substances were beclometasone, budesonide, fenoterol, fluticasone, formoterol, mometasone, montelukast, salbutamol and terbutaline and the combinations of budesonide/formoterol, fenoterol/ipratropium and fluticasone/salmeterol. Main outcome measures Reported ADRs were categorized with respect to distribution on age, sex, type and seriousness of reported ADRs, medications and type of reporter. The unit of analysis was one ADR. Results We located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85 % of reported ADRs were serious including six fatal cases. In total, 57 % of ADRs were reported for boys. One quarter of all ADRs occurred in children up to 1 year of age. Physicians reported the majority of ADRs. Across medicines, the majority of reported ADRs were of the type "psychiatric disorders" (13 % of total ADRs), followed by "respiratory, thoracic and mediastinal disorders" (10 % of total ADRs) and "skin and subcutaneous disorders" (9 % of total ADRs). The largest number of ADRs was reported for budesonide (21 % of total ADRs), followed by salbutamol (20 % of total ADRs) and fluticasone (19 % of total ADRs). For salbutamol, the largest numbers of serious ADRs were "tachycardia", "accidental exposure/incorrect dose administered" and "respiratory failure". Conclusion Only a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious including fatal cases.
International Journal of Clinical Pharmacy, 2014, Vol 36, Issue 6, p. 1222-9