Abstract The Sentinel System is a major component of the United States Food and Drug
Administration's (FDA) approach to active medical product safety surveillance. While …

Increasing availability of electronic health databases capturing real-world experiences with
medical products has garnered much interest in their use for pharmacoepidemiologic and …

Congress mandated the creation of a postmarket Active Risk Identification and Analysis
(ARIA) system containing data on 100 million individuals for monitoring risks associated with …

Tree-based scan statistics have been successfully used to study the safety of several
vaccines without prespecifying health outcomes of concern. In this study, the binomial tree …

Background There is currently conflicting evidence of the association between the use of
selective serotonin reuptake inhibitors (SSRIs) and acute pancreatitis. The SSRI fluoxetine …

Most drug repurposing studies using real-world data focused on validating, instead of
generating, hypotheses. We used tree-based scan statistics to generate repurposing …

Background: Safety issues are detected in about one third of prescription drugs in the years
following regulatory agency approval. Older adults, especially those with chronic kidney …

Purpose It is a priority of the US Food and Drug Administration (FDA) to monitor the safety of
medications used during pregnancy. Pregnancy exposure registries and cohort studies …

Electronic health records (EHRs) have emerged as resources for both the identification of
adverse drug events (ADEs) and general population health surveillance, however questions …

Background Hypothesis-free signal detection (HFSD) methods such as tree-based scan
statistics (TBSS) applied to longitudinal electronic healthcare data (EHD) are increasingly …