Introduction As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. Objective Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. Methods Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agency’s database for suspected adverse drug reactions. For each drug–event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011–2017. Signals in children (aged 0–17 years) were compared with signals in the whole population. Analyses were repeated for diferent age categories, by sex and by therapeutic area. Results In total, 372,345 reports in children resulted in 385 diferent signals concerning asthma therapy. The largest group consisted of psychiatric events (65 signals). Only 30 signals were new, with seven, including herpes viral infections, associated with omalizumab. Stratifcation by age, sex and therapeutic area provided additional new signals, such as hypertrichoses with budesonide and encephalopathies with theophylline. Of all signals in children, 60 (16%) did not appear in the whole population. Conclusions The majority of signals regarding asthma therapy in children were already known, but we also identifed new signals. We showed that signals can be masked if age stratifcation is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals.,
Drug Safety
Department of Medical Informatics

Baan, E.J., de Smet, V.A., Hoeve, C., Păcurariu, A., Sturkenboom, M., de Jongste, J., … Verhamme, K. (2019). Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Drug Safety. doi:10.1007/s40264-019-00870-x