Pradaxa

Pradaxa® (dabigatran etexilate mesylate) capsules is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

This drug is known to lessen the chance of stroke to patients with atrial fibrillation due to a certain kind of heart rhythm disorder. A recognized complication of anti-coagulant drugs is bleeding. This blood thinning drug which is an oral anticoagulant has been linked to over 250 deaths worldwide. It has also been linked to several life-threatening internal bleeding cases. Studies show that patients who take this medication have over a 30% higher risk of heart attack than those taking a drug known as Warfarin.

A 2011 FDA Safety Communication stated that Pradaxa may be more likely to cause life threatening bleeding than other drugs used for this purpose.

The FDA recently posted the following on their website, fda.gov:

Safety Announcement:

[11-02-2012] The U.S. Food and Drug Administration (FDA) has 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). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users.  As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin.  This assessment was done using insurance claims and administrative data from FDA's Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel 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).1 (see Data Summary). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

Facts on Pradaxa

  • Pradaxa is an anticoagulant medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
  • The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.1
  • From approval in October 2010 through August 2012, a total of approximately 3.7 million Pradaxa prescriptions were dispensed, and approximately 725,000 patients received a dispensed prescription for Pradaxa from U.S. outpatient retail pharmacies.2

Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly.  Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes.  The risk of bleeding is a well-recognized risk of anticoagulant drugs.

If you have lost a family member to fatal Pradaxa bleeding, contact our firm to find out your options in seeking compensation for medical bills and the pain and suffering associated with their loss.