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

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...

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Bibliographic Details
Published in:	Drug safety Vol. 37; no. 11; pp. 971 - 980
Main Authors:	Hoffman, Keith B., Demakas, Andrea R., Dimbil, Mo, Tatonetti, Nicholas P., Erdman, Colin B.
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01-11-2014 Adis International Springer Nature B.V
Subjects:	Adverse Drug Reaction Reporting Systems Biological and medical sciences Clinical trial. Drug monitoring Clinical trials Drug Safety and Pharmacovigilance Drug therapy FDA approval General pharmacology Humans Industrial safety Marketing Medical sciences Medicine Medicine & Public Health Original Original Research Article Pharmacology. Drug treatments Pharmacology/Toxicology Product safety Product Surveillance, Postmarketing - trends Program Evaluation Studies United States United States Food and Drug Administration United States North America America Adverse Event Reporting System Median Percent Change National Drug File Reference Terminology Sibutramine Adverse Event Reporting Secondary effect Pharmacovigilance Toxicity Food and Drug Administration Notification
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Summary:	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 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. Results 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. Conclusions Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.
ISSN:	0114-5916 1179-1942
DOI:	10.1007/s40264-014-0225-0