Comparing Pharmacovigilance Outcomes Between FAERS and EMR Data for Acute Mania Patients

Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small/moderate sample size and short follow-up time. The data collected in the post market spontaneous reporting systems such as FAERS as well as Electronic Medical Record (EMR) systems provide crucial information to evaluate post-marketing drug safety. In this paper, we assess the strengths and limitations of FAERS and EMR data in studying the post-marketing pharmacovigilance outcomes for 12 selected antidepressant drugs, and compare the results obtained from these two data sources, and describe key challenges in evidence integration.