ORIGINAL RESEARCH ARTICLE Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

The Author(s) 2014. This article is published with open access at Springerlink.com 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 FD