January 27, 2012

FDA Evaluating Risk of Serious Bleeding Episodes with Prescription Drug Pradaxa

Pradaxa(dabigatran etexilate) is an oral blood thinner that was approved by the US FDA in October 2010. is in the class of anticoagulant (anti-clotting) blood thinners called “direct thrombin inhibitors”. The drug is used to prevent serious blood clots in patients with atrial fibrillation. Atrial fibrillation is a heart condition in which the upper chambers of the heart (atria) fail to contract fully causing potential stagnant blood and clot formation.

Patients with atrial fibrillation are often candidates for long term anticoagulation. Prior to the release of these patients were either treated with oral Coumadin, low molecular weight heparin, or less effective antiplatelet agents such as aspirin.

Recently, studies have shown that patients on have a 33% higher risk of heart attack when compared to previously prescribed medications. The FDA is currently investigating an unusually high number of reports of serious bleeding linked to Pradaxa’s use.

Some of Pradaxa’s side effects include:

- Internal bleeding

- Gastrointestinal bleeding

- Brain hemorrhage

- Kidney bleeding and death

With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C. is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.

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