Safety Review of Post-Market Reports of Serious Bleeding Events

[mainframetech]

I'm posting this since it mentions kidney malfunction. They are
saying that Pradaxa is no worse than Coumarin (see warnings) and
stopping it could lead to stroke. It would be nice if FDA would find
reasons to stop medication rather than to continue it. Personally, I
use Omega-3 and it seems to work just fine. Apparently they had
reports of serious bleeding events, as they call it.

Chris
===================

From: FDA MedWatch
Date: 11/02/2012
Subject: FDA MedWatch - Pradaxa (dabigatran etexilate mesylate): Drug
Safety Communication - Safety Review of Post-Market Reports of Serious
Bleeding Events
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

[Colt T]

Keep in mind the FDA works for the drug co's and not the American
people.