Serious adverse drug events reported to the FDA: analysis of the FDA Adverse Event Reporting System 2006–2014 database.
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.
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