Safety signals concerning asthma drugs in children

Abstract

Background: Asthma medication is amongst the most frequently prescribed drugs in children. In 2016, the European Medicines Agency (EMA) published a new inventory of paediatric therapeutic needs, highlighting the need for more safety information on asthma medication. Aim: To identify safety signals related to asthma medication in children. Method: Spontaneous reports received in the EudraVigilance database between 2011-2015 were investigated. New safety signals were identified through the calculation of the proportional reporting ratio (PRR) as a measure of disproportionality (PRR>1 was considered a signal). Stratification by age and gender was performed. To control for confounding by indication, we restricted to all asthma medication as reference category. Results: 15,284 drug-event pairs from 4,086 individual pediatric safety reports concerning asthma drugs were analysed. New safety signals were found: pneumonia with various inhaled corticosteroids (ICS) (e.g. fluticason: PRR 5.9, 95% CI [4.0-8.8]), adrenal suppression with various ICS (e.g. triamcinolon: PRR 612.4, 95% CI [356.8-1050.8]) and several psychiatric disorders associated with montelukast (e.g. obsessive thoughts: PRR 32.7, 95% CI [13.5-78.7]). Stratifying by gender did not affect signals while restricting to asthma medication influenced the strength of the signal and eliminated confounding by indication. Conclusion: It is important to investigate safety signals in children using spontaneous databases. We confirmed already known signals and identified new safety signals like risk of pneumonia in children using ICS. This association has already been studied in adults (mainly COPD patients) and needs to be further investigated in children.