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:
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