ArticleDrug safety2019
Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.
Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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
8 citing papers in PubMed.
- Article
- Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis.Drug safety · 2026Article
- Identifying High-Risk Medications for Drug-Induced Dystonia: A 20-Year Retrospective Real-World Pharmacovigilance Study Based on FAERS.Health science reports · 2026Article
- Risk of drug eruption associated with the use of tetracyclines, macrolides, and fluoroquinolones: real-world evidence from a pharmacovigilance study utilizing the FDA adverse event reporting system.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Article
- Synergistic toxicity and clinical prioritization of docetaxel combined with nintedanib for non-small cell lung cancer: a real-world safety analysis using the FAERS database.Frontiers in oncology · 2026Article
- Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (ZolgensmaPharmaceuticals (Basel, Switzerland) · 2024Article
- A novel data mining application to detect safety signals for newly approved medications in routine care of patients with diabetes.Endocrinology, diabetes & metabolism · 2021Article
- The Impact of Litigation-Associated Reports on Signal Identification in the US FDA's Adverse Event Reporting System.Drug safety · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems.
objectiveOur objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS).
methodsFAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs-isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis-with and without lawyer-submitted reports. Isotretinoin and atorvastatin have been the subject of high-profile tort litigation regarding other AEs. A lower bound of the 95% confidence interval (CI) of one or more based on three or more reports defined a signal.
resultsCumulative PRRs met signaling criteria in all analyses. For isotretinoin, lawyer-submitted reports increased PRRs for birth defects before 2008, with the largest increase in 2006 (2.9 [95% CI 2.4-3.5] to 3.3 [95% CI 2.8-3.9]); lawyer-submitted reports decreased PRRs for birth defects after 2011, with the largest decrease in 2013 (2.2 [95% CI 2.0-2.5] to 1.9 [95% CI 1.7-2.1]). For atorvastatin, lawyer-submitted reports reduced PRRs for rhabdomyolysis after 2013, with the largest decrease in 2015 (18.0 [95% CI 17.1-19.1] to 15.4 [95% CI 14.5-16.2]). Lawyer-submitted reports had little impact on PRRs for rosuvastatin and rhabdomyolysis.
conclusionsInclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs.
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