The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System
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Prescription drug litigation can result in concentrated influxes of reports submitted to the US FDA Adverse Event Reporting System (FAERS). Rogers et al. recently demonstrated lawyer-submitted reports did not meaningfully distort signals of disproportionate reporting (SDRs) for isotretinoin and atorvastatin ; however, we are aware of examples in which litigation can have significant impacts on SDRs. In this letter, we demonstrate the impact of litigation-associated reports (LARs) on the FAERS overall and using metoclopramide as an example. A boxed warning communicating the risk of tardive dyskinesia (TD) was added to the labeling of metoclopramide in 2009; subsequently, in 2011 the FAERS received almost 10,000 cases of TD listing metoclopramide as a suspect drug .
We used an algorithm to identify LARs received in the FAERS through 31 December 2018. Reports were classified as litigation-associated if either the reporter’s occupation equaled lawyer or if the report’s...
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Conflicts of Interest
Monica A. Muñoz and Gerald J. Dal Pan have no conflicts of interest to declare.
No funding was used for the preparation of this letter.
The views expressed are those of the authors and do not necessarily represent the position of, nor imply endorsement from, the US FDA or the US Government.
- 2.US FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 4 Apr 2019.
- 3.DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.Google Scholar