Comparison Between Paediatric and Adult Suspected Adverse Drug Reactions Reported to the European Medicines Agency: Implications for Pharmacovigilance

Background Databases systematically collecting reports of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance in that they provide on-going large-scale surveillance in the ‘real-world’ setting. Several studies have provided data on ADRs in children reported to national databases. EudraVigilance (EV) is the European Medicines Agency’s (EMA) web-based system for reporting and evaluating suspected ADRs. Due to requirements on pharmaceutical companies to report ADRs that originate both inside and outside Europe, the data in EudraVigilance are global in nature. As such, it is potentially a rich source of information for paediatric pharmacovigilance.