Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

ABSTRACT:

Background

The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA.

Objective

To determine the extent of "stimulated reporting" in the modern-day FAERS database.

Methods

One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websi

SUBMITTER: Hoffman KB 

PROVIDER: S-EPMC4206770 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature