A Database of Pediatric Drug Effects to Evaluate Ontogenic Mechanisms From Child Growth and Development

Abstract

Adverse drugs effects (ADEs) in children are common and may result in disability and death. However, methodologies do not surpass event surveillance to identify and evaluate potential dynamic mechanisms from child growth and development. We generated a database of 460,837 pediatric ADEs using generalized additive models (GAMs) previously shown to identify dynamic risk estimates of adverse drug events 1 . We identified 19,438 significant drug-event risks including known pediatric drug effects exhibiting risk dynamics across child development, such as montelukast-induced psychiatric disorders within the second year of life (Odds Ratio 8.77 [2.51, 46.94]). A data-driven time-series clustering approach resulted in up to 95.2% precision and 97.8% sensitivity for categorizing risk dynamics. We found that our real-world evidence may contain biologically-relevant underpinnings. We curated this database for the research community to enable, for the first time, evaluation of real-world hypotheses of adverse drug effects across child growth and development.