Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
UPDATED 11/02/2012. The FDA evaluated new information about the
risk of serious bleeding associated with use of the anticoagulants
(blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin,
Jantoven, and generics). This assessment was done using insurance
claims and administrative data from FDA’s Mini-Sentinel pilot
of the Sentinel Initiative. The results of this assessment indicate
that bleeding rates associated with new use of Pradaxa do not
appear to be higher than bleeding rates associated with new use of
warfarin, which is consistent with observations from the large
clinical trial used to approve Pradaxa (the RE-LY trial). FDA is
continuing to evaluate multiple sources of data in the ongoing
safety review of this issue. See the Data Summary in the 11/02/2012
Drug Safety Communication below for additional information.
FDA has not changed its recommendations regarding Pradaxa. Pradaxa
provides an important health benefit when used as directed.
Healthcare professionals who prescribe Pradaxa should carefully
follow the dosing recommendations in the drug label, especially for
patients with renal impairment (when kidneys don’t function
normally) to reduce the risk of bleeding. Patients with atrial
fibrillation should not stop taking Pradaxa without first talking
to their healthcare professional. Stopping use of anticoagulant
medications such as Pradaxa can increase the risk of stroke.
Strokes can lead to permanent disability and death.
Read the MedWatch safety alert, including a link to the FDA Drug
Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
Posted: November 2012
