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Label Changes for:

Pradaxa (Dabigatran Etexilate Mesylate) Capsules

April 2013

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

April 2013

 

 

BOXED WARNING

WARNING: DISCONTINUATING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE…
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