ArticleDrug safety2007
Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias.
Article in Drug safety, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 145 papers, 3 of them syntheses that pooled it.
What it found
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Who cites it
145 citing papers in PubMed, 3 syntheses or guidelines pooled it, 238 citations in OpenAlex.
- Hyponatremia Following Antipsychotic Treatment: In Silico Pharmacodynamics Analysis of Spontaneous Reports From the US Food and Drug Administration Adverse Event Reporting System Database and an Updated Systematic Review.The international journal of neuropsychopharmacology · 2021Pooled it
- Bleeding events attributable to concurrent use of warfarin and other medications in high-risk elderly: meta-analysis and Italian population-based investigation.European journal of clinical pharmacology · 2018Pooled it
- Biased safety reporting in blinded randomized clinical trials: meta-analysis of angiotensin receptor blocker trials.PloS one · 2013Pooled it
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- Italian regional data and oropharyngeal adverse events to drugs and vaccines: insights from a 3-year spontaneous reporting (2022-2024).Pharmacological reports : PR · 2026Article
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- Disproportionality analysis of drug-induced myocarditis: Insights from the Food and Drug Administration Adverse Event Reporting System database.The Journal of international medical research · 2026Article
- Patient-Level Risk Characterization of Drug-Associated Hidradenitis Suppurativa Using Machine Learning.medRxiv : the preprint server for health sciences · 2026Article
- Divergent neuropsychiatric and systemic toxicity profiles of abemaciclib and palbociclib: a triangulation study integrating pharmacovigilance, genetic epidemiology, and multi-omics profiling.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- From real-world pharmacovigilance data to clinical practice: a geriatric-specific predictive model for immune-related adverse events in lung cancer based on routine clinical indicators.BMC geriatrics · 2026Article
- Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis.Drug safety · 2026Article
85 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDisproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias).
objectiveTo explore the consequences of safety alerts on reporting disproportionality.
methodsWithin the French national pharmacovigilance database, disproportionality of reporting was tested, using the reporting odds ratio (ROR) and its 95% confidence interval, before and after four safety alerts: valvulopathies with pergolide; tuberculosis with infliximab; strokes with atypical antipsychotics; and rhabdomyolysis with HMG-CoA reductase inhibitors (statins) [after cerivastatin withdrawal].
resultsNo cases of valvulopathy were reported in association with pergolide before the safety alert and 63 cases were reported after the alert, (ROR 9400; 95% CI 4300, 20 000), of which five had occurred before the alert. Twenty-five reports mentioned rhabdomyolysis associated with statins (not including cerivastatin) before the safety alert (ROR 5.8; 95% CI 3.8, 9.0), and 63 did so after the alert (ROR 9.4; 95% CI 7.0, 13.0). Approximately 280 cases involving cerivastatin were reported after its withdrawal. There were two reports of tuberculosis associated with infliximab before the alert (ROR 1500; 95% CI 130, 18 000) and seven after the alert (ROR 430; 95% CI 110, 1700). There was one report of a stroke in association with atypical antipsychotic treatment before the safety alert (ROR 0.10; 95% CI 0.01, 0.63) and 16 after the alert (ROR 1.10; 95% CI 0.70, 1.90). After excluding events involving treatment with anticoagulant agents, the RORs for stroke in association with atypical antipsychotic treatment were 0.14 (95% CI 0.02, 1.00) before the alert and 2.0 (95% CI 1.2, 3.4) after the alert.
conclusionDisproportionality in spontaneous reporting databases increases after a safety alert because of increased reporting of the event of interest, including reports of such events that occurred before the alert. This may overflow to increased reporting of the event in association with other drugs.
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