A Surveillance Study On The Safety Of Pediatric Drugs In A Spontaneous Reporting System

Children are at exceptionally high risk for adverse drug events because ofphysiological immaturity, lack of testing and information on medications, availabilityof appropriate medication formulations and strengths. Spontaneous reporting systems(SRSs) provide ongoing large-scale surveillance in the real world‘setting,particularly with safety signals from populations not studied in clinical trials such aschildren, and thus is an important tool to detect novel post-marketed adverse drugreactions, especially drug interaction adverse effects in the population of interest.In this study, the reports in United States Food and Drug Administration (FDA)Adverse Event Reporting System (FAERS) database from January,2004to June,2012are analyzed for exploring the association of acute kidney injury (AKI) withseveral drugs and drug-drug interactions by using data mining methods. This studyaims to provide useful safety information for pediatric drugs which is valuable forbalancing the risk/benefit of pediatric drug use and rational use of drugs for children.Firstly, the current situation of children’s medication safety monitoring at homeand abroad is analyzed which reveals the necessity and importance of the surveillancestudy on the safety of pediatric drugs in a spontaneous reporting system. Secondly, asearch of FAERS is performed within the following age groups: infants (0-1years),early childhood (2–5years), middle childhood (6–11years), adolescents (12–17years), adults (18-64years) and elderly (≥65years). According to the data, there aredifferences in children and adults in regard to age, gender and seriousness of outcome.Thirdly, the paper explores the safety signals associated with some commonly useddrugs in children and the association of acute kidney injury (AKI) with several drugsby using data mining methods such as frequentist approaches and Bayesianapproaches.The results provide evidence that Nonsteroidal Anti-Inflammatory Drugs(NSAIDs) are an important cause of AKI in Children. In addition, the adverse eventsinvolved of kidney, liver, teeth and blood system associated with ibuprofen,acetaminophen, ceftriaxone, amoxicillin and ciprofloxacin in children aresignificantly different from those in adults. Fourthly, by using methods forquantitative drug–drug interaction detection in FAERS, the results provide evidencethat treatment with the combination of acetaminophen and ibuprofen in children might be associated with increased risk of AKI. Finally, some policy recommendations areput forward in view of the existing problems of pediatric drug safety monitoring andsurveillance in China.