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Cited by 211Pharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcareData-Driven Disease Surveillance

The Weber effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010

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Hoffman, Keith B., Dimbil, Mo, Erdman, Colin B., Tatonetti, Nicholas P., Overstreet, Brian M.·2014·Drug Safety
DOI 10.1007/s40264-014-0150-2PMC PMC3975089
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Abstract

BACKGROUND: The United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance programs. Sometimes cited as a limitation to the usefulness of FAERS, however, is the 'Weber effect,' which is often summarized by stating that AE reporting peaks at the end of the second year after a regulatory authority approves a drug. Weber described this effect in 1984 based upon a single class of medications prescribed in the United Kingdom. Since that time, the FDA has made a concerted effort to improve both reporting and the database itself. Both volume and quality of AE reporting has dramatically improved since Weber's report, with an estimated 800,000 yearly reports now being logged into FAERS. OBJECTIVE: The aim of this study was to determine if current FAERS reporting follows the trend described by Weber. METHODS: Sixty-two drugs approved by the FDA between 2006 and 2010 were included in this analysis. Publicly available FAERS data were used to assess the 'primary suspect' AE reporting pattern for up to a 4-year period following each drug's approval date. RESULTS: A total of 334,984 AE reports were logged into FAERS for the 62 drugs analyzed here. While a few of the drugs demonstrated what could be considered 'Weber effect' curves, a majority of the drugs showed little evidence for the effect. In fact, the general AE reporting pattern observed in this study appears to consist simply of increasing case counts over the first three quarters after approval followed by relatively constant counts thereafter. CONCLUSIONS: Our results suggest that most of the modern adverse event reporting into FAERS does not follow the pattern described by Weber. Factors that may have contributed to this finding include large increases in the volume of AE reports since the Weber effect was described, as well as a concerted effort by the FDA to increase awareness regarding the utility of post-marketing AE reporting.

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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 [51]

    The Discussion and Conclusions report little evidence of a general Weber-effect pattern among 62 drugs approved from 2006 to 2010. That supports the Weber-effect portion, but the paper does not establish that FAERS reporting after 2000 is broadly unaffected by reporting biases, including notoriety bias. (LLM, conf=0.87)

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Cited by

Sorted by citations

Authors
Hoffman, K. B., Dimbil, M., Erdman, C. B., Tatonetti, N. P., & Overstreet, B. M.
Affiliations
Columbia University (US)
Corresponding author
Hoffman, Keith B.
ORCID
Tatonetti, Nicholas P.
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2014-03-19
Volume
37
Issue
4
Pages
283-294
ISSN
  • 0114-5916 (ISSN-L)
  • 1179-1942
DOI
10.1007/s40264-014-0150-2
PMC
PMC3975089
OpenAlex
W2046584449
Cited by
211
References
2
Citations by year
2026: 52 · 2025: 30 · 2024: 23 · 2023: 13 · 2022: 17 · 2021: 18 · 2020: 11 · 2019: 10 · 2018: 10 · 2017: 16 · 2016: 2 · 2015: 7 · 2014: 2
FWCI
6.72
Type
journal article
Language
en
Update notices
correction (2014-04-09)
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)
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
FDA Adverse Event Reporting System, adverse event reporting, post-marketing safety surveillance, drug approval, FDA
MeSH terms
Humans, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration, Databases, Factual, Adverse Drug Reaction Reporting Systems, Drug Approval, Drug-Related Side Effects and Adverse Reactions

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