Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011

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.