Abstract
Introduction
Adverse reactions with an outcome of death are inherently important for pharmacovigilance organizations to evaluate. Prior efforts to systematically evaluate individual case safety reports (ICSRs) with an outcome of death have been limited to high-level summaries.
Objective
The aim of this study was to characterize ICSRs with an outcome of death contained in the US FDA Adverse Event Reporting System (FAERS) database.
Methods
All ICSRs received through 31 December 2017 reporting an outcome of death were characterized by patient demographics, suspect product(s), adverse events, and reporter type. Using the ICSR’s narrative and reporter information, we classified ICSRs by source to include those from industry-sponsored programs, poison control centers, specialty pharmacies, and litigation. Additionally, a random sample of ICSRs was evaluated for completeness of structured data fields and manually reviewed for the availability of key information in the narrative (i.e. cause of death, medical history, and causality assessment).
Results
Overall, 1,053,716 ICSRs with a death outcome were received in the study period. Ten medications treating conditions for malignancies, pain, and kidney disease accounted for nearly 20% of all fatal ICSRs. ICSRs originating from industry-sponsored programs, poison control centers, litigation, and specialty pharmacies accounted for 14%, 6.5%, 5.0%, and 3.3% of all fatal ICSRs, respectively. ICSRs in which the only adverse event coded was ‘death’ were more likely to be missing structured data and less likely to include key information in the narrative.
Conclusion
Understanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome.
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Funding
No sources of funding were used to assist in the preparation of this study.
Conflict of interest
Kathryn Marwitz, S. Christopher Jones, Cindy Kortepeter, Gerald Dal Pan, and Monica Muñoz have no conflicts of interest that are directly relevant to the content of this study.
Ethics approval
This study was granted an exemption for review by the US FDA Institutional Review Board.
Data sharing
FAERS data are available via the FAERS Public Dashboard and as Quarterly Data files. Additionally, individual case reports can be requested via a Freedom of Information Act request to the FDA. Additional details can be found at https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.
Additional information
Kathryn Marwitz was employed by Purdue University College of Pharmacy at the time this manuscript was written.
The views expressed in this article are those of the authors and do not necessarily represent the position of, nor imply endorsement from, the US FDA or the US Government.
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Marwitz, K., Jones, S.C., Kortepeter, C.M. et al. An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System. Drug Saf 43, 457–465 (2020). https://doi.org/10.1007/s40264-020-00908-5
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DOI: https://doi.org/10.1007/s40264-020-00908-5