Published Research Download

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

Stimulated Reporting: The Impact of FDA Alerts on Real World Data from FAERS“Stimulated reporting,” is the concept that public disclosure of a safety issue by the issuance of an FDA alert or warning, or the clustering of adverse event reports triggered by consumer-based “support group” and/or litigation, will result in substantially increased reporting rates for the affected drug.

It has important implications regarding the utility of post-marketing adverse events data, as alert-driven shifts in reporting could impact the accuracy of comparative research and related analytical methods such as disproportionality analysis. refutes this widely held assumption.

Published in the premier drug risk assessment journal, Drug Safety, Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)" refutes this widely held assumption.

 

Report Summary:
  • AdverseEvents’ report analyzed both overall and adverse event-specific reporting before and after 100 FDA alerts, and found no discernable pattern of increased reporting.
  • The report clearly demonstrates that modern FAERS data does not suffer from the biases that would be introduced by significant shifts in reporting owing to the issuance of FDA alerts.
  • The report bolsters AdverseEvents’ convictions and substantiates evidence that FAERS data is not only relevant but vital in determining the overall safety profile of all FDA approved prescription drugs.

 

...For full access to this free report, fill out the form