Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database

Background: The Food and Drug Administration (FDA)’s Adverse Event Reporting System (FAERS) is a post-marketing surveillance system which relies on spontaneous reports of adverse drug reactions (ADRs). Our objective was to evaluate how black box warning (BBW) updates impact ADR reporting rates. Research Design and Methods: We searched MEDWATCH for all BBW updates issued between January 2014 and December 2016 and categorized them as new, major, and minor. Rates of relevant ADR reports from the FAERS database in the 4 years preceding and following a BBW update were assessed among the different BBW categories. Results: Forty BBW updates were included (16 major, 3 new, and 21 minor). A meaningful increase in the proportion of relevant ADRs of all ADRs reported following BBW updates was documented for 53% of new or major updates and 24% of minor updates (p = 0.06). The median percentage of reported relevant ADRs increased by 5% following new and major BBW updates and decreased by 30% following minor BBW updates (p = 0.3). Conclusions: Reporting of adverse events to the FAERS database is affected by the severity and timing of related BBW updates, highlighting the drawbacks of spontaneous reporting systems. Regulators should promote proactive pharmacovigilance strategies to cope with these limitations.