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

TLDR

The FDA’s Adverse Event Reporting System (FAERS) receives nearly one million drug‑safety reports annually, serving as a major post‑marketing surveillance resource. This study examined whether FDA alerts stimulate adverse‑event reporting by analyzing 100 drugs approved between 2001 and 2010. Researchers extracted FDA alerts from MedWatch and the FDA website and used publicly available FAERS data to compare primary suspect adverse‑event reports for up to four quarters before and after each alert. Most drugs showed no significant change in reporting after alerts, with short‑term increases in 21 real versus 25 sham alerts and long‑term increases in 24 real versus 28 sham alerts, indicating that modern FAERS reporting is largely unaffected by FDA alerts.

Abstract

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.To determine the extent of "stimulated reporting" in the modern-day FAERS database.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 websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert.A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase.Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.