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Cited by 118Pharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcareData-Driven Disease Surveillance

Stimulated reporting: the impact of US Food and Drug Administration-issued alerts on the Adverse Event Reporting System (FAERS)

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Hoffman, Keith B., Demakas, Andrea R., Dimbil, Mo, Tatonetti, Nicholas P., Erdman, Colin B.·2014·Drug Safety
DOI 10.1007/s40264-014-0225-0PMC PMC4206770
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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 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.

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  • Modern FAERS reporting after 2000 is not substantially influenced by reporting biases such as notoriety bias and Weber effect.

    “The modern FAERS reporting (after 2000) is not substantially influenced by the aforementioned reporting biases (50, 51)”

    From The Changing Face of Drug-induced Adrenal Insufficiency in the Food and Drug Administration Adverse Event Reporting System (2022) · cites this paper as [50]

    The Conclusion says modern FAERS reporting trends do not appear substantially affected by FDA alerts, and the Introduction says the Weber effect may be less concerning than in the past. Those passages support a narrower claim about alert-driven reporting and a qualified observation about the Weber effect; they do not establish that reporting after 2000 is broadly unaffected by reporting biases such as notoriety bias. (LLM, conf=0.88)

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References 70 · Cited by 118

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Authors
Hoffman, K. B., Demakas, A. R., Dimbil, M., Tatonetti, N. P., & Erdman, C. B.
Affiliations
Columbia University (US)
Corresponding author
Hoffman, Keith B.
ORCID
Tatonetti, Nicholas P.
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2014-09-26
Volume
37
Issue
11
Pages
971-980
ISSN
  • 0114-5916 (ISSN-L)
  • 1179-1942
DOI
10.1007/s40264-014-0225-0
PMC
PMC4206770
OpenAlex
W1991993840
Cited by
118
References
70
Citations by year
2026: 14 · 2025: 11 · 2024: 12 · 2023: 8 · 2022: 7 · 2021: 3 · 2020: 7 · 2019: 29 · 2018: 9 · 2017: 8 · 2016: 4 · 2015: 5 · 2014: 1
FWCI
4.48
Type
journal article
Language
en
Open access
Licence
Locations
  • Drug Safety (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
National Institute of General Medical Sciences (R01GM107145)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Health Sciences › Medicine › Epidemiology › Data-Driven Disease Surveillance
Keywords
adverse event reporting, FDA warning, FDA Adverse Event Reporting System, post-marketing safety surveillance, MedWatch, drug safety warnings, drug safety signals
MeSH terms
Humans, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration, Program Evaluation, Adverse Drug Reaction Reporting Systems

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