The FDA has received reports of significant bleeding events associated with Pradaxa (dabigatran etexilate mesylate).
The FDA will release new information on the risk of bleeding and Pradaxa as soon as it is available.
For additional information, go to: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
Pradaxa (dabigatran etexilate mesylate) Risk of (Hemorrhaging) Bleeding Events (12.7.11)
December 7, 2011
