Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Lindsay N. Moreland-Head; James C. Coons; Amy L. Seybert; Matthew P. Gray; Sandra L. Kane‐Gill

doi:10.1177/1074248420984082

January 6, 2021Journal of Cardiovascular Pharmacology and Therapeutics

Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

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Why the study?

Cardiac arrhythmias other than QTc prolongation represent an emerging focus for pharmacovigilance and medication safety.

Can disproportionality analysis of the FAERS database identify previously unknown drug-associated causes of cardiac arrhythmias?

Key Points

To identify previously unrecognized drug-associated causes of cardiac arrhythmias by applying disproportionality analysis to post-marketing safety data.
Conducted a retrospective disproportionality analysis using adverse drug event records from the FDA Adverse Event Reporting System (FAERS) database.
Evaluated reported drug-associated cardiac arrhythmias with an emphasis on adverse events beyond standard QTc prolongation.
The majority of drug-associated arrhythmias reported in the database represented previously unknown associations, revealing potential novel drug causes.
Identified non-QTc cardiac arrhythmias as an emerging target area for post-marketing medication safety and pharmacovigilance monitoring.

Structured PICO

Can disproportionality analysis of the FAERS database identify previously unknown drug-associated causes of cardiac arrhythmias?

P

Population

Adverse event reports of cardiac arrhythmias in the FDA Adverse Event Reporting System (FAERS) database

I

Intervention

Disproportionality analysis

O

Outcome

Identification of previously unknown drug-associated causes of cardiac arrhythmiassafety

Disproportionality analysis of the FAERS database can identify previously unknown drug-associated causes of cardiac arrhythmias, serving as a valuable pharmacovigilance tool.

Implication

May warrant arrhythmia vigilance for FAERS-flagged drugs; leaves open causal confirmation before practice change.

Abstract

Upon retrospective analysis of the FAERS database, the majority of drug-associated arrhythmias reported were unknown suggesting new potential drug causes. Cardiac arrhythmias other than QTc prolongation are a new area of focus for pharmacovigilance and medication safety. Consideration of future studies should be given to using the FAERS database as a timely pharmacovigilance tool to identify unknown adverse events of medications.

Discussion

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Cite This Study

Moreland-Head et al. (2021) studied this question.

synapsesocial.com/papers/69c5e6dc7090fce65e4ad84f https://doi.org/10.1177/1074248420984082

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Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Key Points

Structured PICO

Implication

Abstract

Discussion

Cite This Study

Use of Disproportionality Analysis to Identify Previously Unknown Drug-Associated Causes of Cardiac Arrhythmias Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Key Points

Structured PICO

Implication

Abstract

Discussion

Cite This Study

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