ArticleBMJ (Clinical research ed.)2022
Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study.
Article in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.
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Who cites it
45 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Article
- Post-marketing safety surveillance of EGFR-targeted agents and disseminated intravascular coagulation risk: a disproportionality analysis based on the FDA Adverse Event Reporting System.International journal of clinical pharmacy · 2026Article
- Hepatic Safety of Ketamine and Esketamine for Treatment-Resistant Depression: A Real-World Cohort Study.Journal of clinical psychopharmacology · 2026Article
- Patient-Level Risk Characterization of Drug-Associated Hidradenitis Suppurativa Using Machine Learning.medRxiv : the preprint server for health sciences · 2026Article
- Peripheral and central nervous system toxicities of Bruton tyrosine kinase Inhibitors: a real-world pharmacovigilance study.Frontiers in medicine · 2026Article
- Ranking the Diabetes-related Safety Profile of Different Statin Drugs.Current pharmaceutical design · 2026Article
- Signal mining for non-bleeding adverse event in novel oral anticoagulants: a pharmacovigilance study based on FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Real-world pharmacovigilance of drug-related bone metabolism disorders: integrating FAERS and VigiAccess with a Bradford Hill-based causal plausibility assessment.Frontiers in pharmacology · 2026Article
- Targeted drug repurposing in medication-related osteonecrosis of the jaw: a review of teriparatide and pentoxifylline/α-tocopherol protocols.Frontiers in medicine · 2026Review
- QT-related adverse events with ondansetron and olanzapine: a real-world FAERS analysis with implications for oncology anti-emetic practice.Frontiers in pharmacology · 2026Article
- Thromboembolic adverse events associated with TPO-RA in ITP treatment: a pharmacovigilance analysis of the FDA Adverse Event Reporting System.Frontiers in immunology · 2026Article
- Reply: Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database.The Annals of pharmacotherapy · 2025Article
- Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD).Pharmacoepidemiology and drug safety · 2025Article
- A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database.Cancer medicine · 2025Article
- Disproportionality Analysis of Ivabradine in the US FDA Adverse Event Reporting System: A Real-World Study Across Overall and Indication-Specific Populations.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025Article
- Real-World Evidence of Neuropsychiatric Adverse Reactions to Isotretinoin: Insights from EudraVigilance (2005-2025).Pharmaceuticals (Basel, Switzerland) · 2025Article
- ToxBERT: an explainable AI framework for enhancing prediction of adverse drug reactions and structural insights.Journal of pharmaceutical analysis · 2025Article
- Fracture events associated with GLP-1 receptor agonists in FDA adverse events reporting system.Acta diabetologica · 2025Article
- Gastrointestinal adverse events associated with Lenvatinib versus Lenvatinib plus Pembrolizumab: A pharmacovigilance study in FDA adverse event reporting system.Scientific reports · 2025Article
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Funding
Abstract
objectiveTo characterize potential drug safety signals identified from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), from 2008 to 2019, to determine how often these signals resulted in regulatory action by the FDA and whether these actions were corroborated by published research findings or public assessments by the Sentinel Initiative.
designCross sectional study.
settingUSA. POPULATION: Safety signals identified from the FAERS and publicly reported by the FDA between 2008 and 2019; and review of the relevant literature published before and after safety signals were reported in 2014-15. Literature searches were performed in November 2019, Sentinel Initiative assessments were searched in December 2021, and data analysis was finalized in December 2021.
main outcome measuresSafety signals and resulting regulatory actions; number and characteristics of published studies, including corroboration of regulatory action as evidenced by significant associations (or no associations) between the drug related to the signal and the adverse event.
resultsFrom 2008 to 2019, 603 potential safety signals identified from the FAERS were reported by the FDA (median 48 annually, interquartile range 41-61), of which 413 (68.5%) were resolved as of December 2021 (372 of 399 (93.2%) signals ≥3 years old were resolved). Among the resolved safety signals, 91 (22.0%) led to no regulatory action and 322 (78.0%) resulted in regulatory action, including 319 (77.2%) changes to drug labeling and 59 (14.3%) drug safety communications or other public communications from the FDA. For a subset of 82 potential safety signals reported in 2014-15, a literature search identified 1712 relevant publications; 1201 (70.2%) were case reports or case series. Among these 82 safety signals, 76 (92.7%) were resolved, of which relevant published research was identified for 57 (75.0%) signals and relevant Sentinel Initiative assessments for four (5.3%) signals. Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of the 57 (29.8%) resolved safety signals; none of the relevant Sentinel Initiative assessments corroborated FDA regulatory action.
conclusionsMost potential safety signals identified from the FAERS led to regulatory action by the FDA. Only a third of regulatory actions were corroborated by published research, however, and none by public assessments from the Sentinel Initiative. These findings suggest that either the FDA is taking regulatory actions based on evidence not made publicly available or more comprehensive safety evaluations might be needed when potential safety signals are identified.
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