Dabigatran (Pradaxa), Warfarin and GI Bleed, Intracerebral Hemorrhage

Project Title Dabigatran (Pradaxa), Warfarin and GI Bleed, Intracerebral Hemorrhage
Date Posted
Monday, February 11, 2013
Project ID
MSY3_MPR41
Status
Complete
Deliverables
Related Links
Description

Modular program-based one-time assessment of the risk of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events associated with use of the anticoagulants (blood thinners) dabigatran and warfarin in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Queries were run requiring a pre-existing condition of atrial fibrillation in any care setting and separately without a pre-existing condition requirement. Outcomes of GIH and ICH were assessed in inpatient and emergency department settings. Programs were executed in August 2012.

The information contained in this report is associated with an FDA MedWatch alert issued on November 2, 2012.

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Medical Product
Coumadin
Pradaxa
anticoagulant
blood thinner
dabigatran
warfarin
Health Outcome
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
Population / Cohort
All individuals
Time Period
2010 - 2011
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER