Paediatric adverse drug reactions following use of

Authors: Lise Aagaard Ebba Holme Hansen

Publish Date: 2014/10/07

Volume: 36, Issue: 6, Pages: 1222-1229

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Abstract

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

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