An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System

ConclusionUnderstanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome.

http://link.springer.com/10.1007/s40264-020-00908-5

Source: Drug Safety - January 23, 2020 Category: Drugs & Pharmacology Source Type: research