Serious adverse drug events reported to the FDA: analysis of the FDA Adverse Event Reporting System 2006–2014 database.
Sonawane KB, Cheng N, Hansen RA. Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database. J Manag Care Spec Pharm. 2018;24(7):682-690. doi:10.18553/jmcp.2018.24.7.682.
This retrospective study reviewed serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration between 2006 and 2014. Over the 9-year study period, the number of serious ADEs reported doubled and a small number of medications accounted for a significant number of serious and fatal ADEs.