ArticlePharmaceutical medicine2019
Adverse Drug Reaction Risk Measures: A Comparison of Estimates from Drug Surveillance and Randomised Trials.
Article in Pharmaceutical medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 20 citations in OpenAlex.
- Cross-national pharmacovigilance of drug-induced intestinal obstruction: disproportionality signals in FAERS and external validation in JADER.Frontiers in pharmacology · 2026Article
- Reported drug spectrum and disproportionality signals for malignant neoplasm progression in FAERS: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Article
- Drug spectrum and disproportionality signals for diabetes insipidus in FAERS: multi-method analysis, JADER cross-database assessment, and PubMed-based case-level evidence.Frontiers in pharmacology · 2026Article
- Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER.BMC pharmacology & toxicology · 2025Article
- Drug-induced kidney stones: a real-world pharmacovigilance study using the FDA adverse event reporting system database.Frontiers in pharmacology · 2025Article
- Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025Article
- Is it appropriate to conduct a disproportionality analysis using a spontaneous reporting database to investigate whether drug-related adverse events are dose-dependent?Frontiers in pharmacology · 2025Article
- New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?Pharmacy (Basel, Switzerland) · 2024Review
- The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline.Frontiers in pharmacology · 2024Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Status and strategies of college English teaching using adaptive deep learning from the perspective of multiculturalism.Frontiers in psychology · 2022Article
- Movement disorders and use of risperidone and methylphenidate: a review of case reports and an analysis of the WHO database in pharmacovigilance.European child & adolescent psychiatry · 2021Review
Corrections and comments
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Authors and funding
5 authors at 1 institution in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMost drug regulatory agencies and pharmaceutical companies hold databases of spontaneous reports of suspected adverse drug reactions (ADRs). Detection systems for ADR signals have been created by specialists to analyse such reports, based on the concept of disproportionality, in order to support safety decision making. However, these measures are often misinterpreted by non-specialists in pharmacovigilance.
objectivesOur aim was to assess agreement between estimates of risk from spontaneous reports of suspected ADRs and estimates of risks of ADRs from randomised controlled trials (RCTs).
methodsFrom 150 drugs randomly selected from the US Food and Drug Administration's Adverse Event Reporting System (FAERS), we identified drugs where FAERS provided reporting odds ratios (RORs) and corresponding systematic reviews from the Cochrane database gave (pooled) odds ratios (ORs) for the same drugs and adverse reactions. We assessed agreement between (ln) RORs and (ln) ORs using the Pearson correlation coefficient and the Bland-Altman agreement method, and performed sensitivity analyses.
resultsWe identified 6 drugs and 125 ADRs. Overall, there was a weak correlation (r = 0.20) between RORs (FAERS) and ORs (RCTs). However, we observed a stronger correlation (r = 0.78) between RORs and ORs for one drug (roflumilast) that received market approval relatively recently (2011).
conclusionsSpontaneous reporting of suspected ADRs is an important tool for regulatory agencies and pharmaceutical companies in making decisions and detecting drug safety signals. Although there was moderate-to-strong agreement between ADR risk estimates from drug surveillance and RCTs for one drug, this study illustrates the current recommendations not to use disproportionality measures as valid proxies for risk estimates.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.