ArticlePharmacoepidemiology and drug safety2018
Characteristics of drugs safety signals that predict safety related product information update.
Article in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed.
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- Peripheral nervous system safety signals of antibody-drug conjugates: cross-database reproducibility and labeling gaps identified using FAERS, JADER, and CVARD.Frontiers in pharmacology · 2026Article
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- Adverse events associated with Lutetium-177-PSMA-617 (PluvictoBMC cancer · 2025Article
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- Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors.Drug, healthcare and patient safety · 2024Article
- Drug Repurposing Using FDA Adverse Event Reporting System (FAERS) Database.Current drug targets · 2024Review
- Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study.Drug safety · 2023Article
- Initiatives, Concepts, and Implementation Practices of the Findable, Accessible, Interoperable, and Reusable Data Principles in Health Data Stewardship: Scoping Review.Journal of medical Internet research · 2023Article
- Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature.Drug safety · 2023Article
- A New Drug Safety Signal Detection and Triage System Integrating Sequence Symmetry Analysis and Tree-Based Scan Statistics with Longitudinal Data.Clinical epidemiology · 2023Article
- Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2021Article
- In response to: "Reply to research letter".Journal of the American Academy of Dermatology · 2020Article
- Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature.Systematic reviews · 2020Article
- Characteristics of drugs safety signals that predict safety related product information update.Pharmacoepidemiology and drug safety · 2018Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.
methodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.
resultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug-event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).
conclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.
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