ArticleDrug safety2016
An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies.
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
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Who cites it
35 citing papers in PubMed.
- Masking effect in the Spanish spontaneous reporting database FEDRA.European journal of clinical pharmacology · 2026Article
- Analysis of adverse event reporting with casimersen: a pharmacovigilance study based on the United States food and drug administration adverse event reporting system database.International journal of clinical pharmacy · 2026Article
- Drug-related retinal detachment pharmacovigilance signals in the real world: evidence from the FDA Adverse Event Reporting System.Eye (London, England) · 2025Article
- Hepatobiliary Adverse Events Linked to Immune Checkpoint Inhibitors: A Real-World Pharmacovigilance Analysis Using FAERS Data.Thoracic cancer · 2025Article
- Risk comparison of adverse reactions between gemcitabine monotherapy and gemcitabine combined with albumin-bound paclitaxel in pancreatic cancer: insights from the FDA Adverse Event Reporting System (FAERS) database.BMC pharmacology & toxicology · 2025Article
- Disproportionality Analysis and Causal Inference in Drug Safety.Pharmaceutical medicine · 2025Review
- Real-world pharmacovigilance insights into drug-induced risk of alopecia.Frontiers in pharmacology · 2025Article
- Drug-induced herpes zoster: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024.Frontiers in pharmacology · 2025Article
- The real-world analysis of adverse events with azacitidine: a pharmacovigilance study based on the FAERS and WHO-VigiAccess databases.Frontiers in pharmacology · 2025Article
- Drug-Related Keratitis: A Real-World FDA Adverse Event Reporting System Database Study.Translational vision science & technology · 2024Article
- Article
- New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?Pharmacy (Basel, Switzerland) · 2024Review
- Adverse events of topical ocular prostaglandin medications for glaucoma treatment: a pharmacovigilance study based on the FAERS database.Therapeutic advances in drug safety · 2024Article
- The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline.Frontiers in pharmacology · 2024Article
- Comparing the adverse effects of ketamine and esketamine between genders using FAERS data.Frontiers in pharmacology · 2024Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS).Drug safety · 2022Article
- Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study.British journal of clinical pharmacology · 2022Article
- Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Article
- Neurological Adverse Events Associated With Esketamine: A Disproportionality Analysis for Signal Detection Leveraging the FDA Adverse Event Reporting System.Frontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAlthough it seems reasonable to suppose that a drug that increases the risk of an adverse event might tend to show increased disproportionality statistics in spontaneous reporting databases, that relationship is not clear. Therefore, an empirical approach was taken to investigate the relationship between proportional reporting ratios (PRRs) and relative risk (RR) estimates from formal studies in a set of known adverse drug reactions (ADRs).
methodsDrug-event pairs that were the subject of pharmacovigilance-driven European regulatory actions from 2007 to 2010 were selected. Only pairs having RR derived from formal studies and where it was considered that there was well-established evidence supporting the actions were included. A best estimate of the RR for each ADR was chosen based on pre-specified rules. PRRs were then calculated in Eudravigilance using only those cases reported before the date of first recognition of the ADR in the medical community. An additional analysis was carried out in FEDRA, the Spanish spontaneous reports database. A descriptive analysis and an orthogonal regression model were performed.
resultsFrom an initial dataset of 78 drug-event pairs, 15 were selected. The regression model (ln RR = 0.203 + 0.463 × ln PRR) showed a significant (p < 0.001) correlation between RR and PRR in Eudravigilance. None of the ADR-related variables analysed modified the relationship. Exploratory results in FEDRA went in the same direction.
conclusionsDisproportionality measures should not replace formal studies but could provide an initial indication of the likely clinical importance of an ADR, should the signal be confirmed subsequently. Whether the same conclusions can be applied to other datasets should be further studied.
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