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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Related Experiment Video

Updated: May 9, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Published on: February 28, 2012

Dabigatran-dronedarone interaction in a spontaneous reporting system.

Pranav K Gandhi¹, William M Gentry, Michael B Bottorff

¹School of Pharmacy, South College, Knoxville, TN 37922, USA. pgandhi@southcollegetn.edu

Journal of the American Pharmacists Association : Japha

|July 30, 2013

Summary

Concurrent use of dabigatran and dronedarone showed a similar risk of bleeding events compared to dabigatran alone. This study analyzed Food and Drug Administration Adverse Event Reporting System data to assess bleeding risks in patients.

Related Experiment Videos

Last Updated: May 9, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Published on: February 28, 2012

Area of Science:

Pharmacovigilance
Cardiovascular Pharmacology
Drug Safety

Background:

Dabigatran and dronedarone are medications used for cardiovascular conditions.
Concurrent use of these drugs may pose a risk of bleeding events.
Understanding this risk is crucial for patient safety.

Purpose of the Study:

To investigate the bleeding risk associated with concurrent dabigatran-dronedarone use versus dabigatran monotherapy.
To identify patient characteristics linked to bleeding events during combined therapy.

Main Methods:

Retrospective data mining of the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Analysis of cases from October 2010 to December 2011 in the United States.
Comparison of bleeding event reports between dabigatran-dronedarone users and dabigatran-only users.

Main Results:

108 reports of dabigatran-dronedarone interactions were identified, with 51 associated with bleeding events.
The odds ratio for bleeding with dabigatran-dronedarone was 13.80 (95% CI 9.45-20.14) compared to no use.
The odds ratio for bleeding with dabigatran alone was 16.06 (95% CI 15.00-17.19) compared to no use.

Conclusions:

The reporting likelihood of bleeding events in patients using dabigatran alone was comparable to those using dabigatran and dronedarone concurrently.
This suggests that the addition of dronedarone to dabigatran does not significantly increase the reported risk of bleeding events.