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Can I read Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports on EtoBox?
Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports by Esmé J. Baan; Veronique A. de Smet; Christina E. Hoeve; Alexandra C. Pacurariu; Miriam C. J. M. Sturkenboom; Johan C. de Jongste; Hettie M. Janssens; Katia M. C. Verhamme is a Medicine article available to read on EtoBox.
What is Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports about?
## 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 different age categories, by sex and by therapeutic area. ## Results In total, 372,345 reports in children resulted in 385 different signals concerning asthma therapy. The largest group consisted of psychiatric events (65 signals). Only 30 signals were new, with seven, including herpes viral infections, associa
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- Author
- Esmé J. Baan; Veronique A. de Smet; Christina E. Hoeve; Alexandra C. Pacurariu; Miriam C. J. M. Sturkenboom; Johan C. de Jongste; Hettie M. Janssens; Katia M. C. Verhamme
- Publisher
- Springer Science and Business Media LLC
- Published
- 2019
- Language
- EN
- Field
- Medicine (Health Sciences)