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Label Changes for:

Pradaxa (dabigatran etexilate mesylate) Capsules

December 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

December 2013

ADVERSE REACTIONS

Postmarketing Experience
  • Esophageal ulcers

 

April 2013 

BOXED WARNING

WARNING: DISCONTINUATING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKEā€¦
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