The U.S. Food and Drug Administration (FDA) is warning doctors, health care providers and the public that Pradaxa (dabigatran etexilate mesylate), a blood thinner or anticoagulant, should not be used to prevent stroke or blood clots in patients with mechanical or prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because it was noticed that patients on Pradaxa were more likely to experience strokes, heart attacks, and blood clots on the mechanical heart valves than were users of the anticoagulant warfarin or Coumadin. There were also more bleeding episodes after aortic, mitral, tricuspid or pulmonic valve surgery in patients taking Pradaxa instead of warfarin.
Pradaxa is a blood-thinning medication that was used to help reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF) or a fib, a common abnormal heart rate where the upper portion of the heart, or atria, beats faster or irregularly. Patients who have atrial fibrillation are at a higher risk of dislodging blood clots to other areas of the body that could lead to the development of a stroke or heart attack. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. The FDA is issuing a warning against the use of Pradaxa in patients with artificial heart valves.
Boehringer Ingelheim, the German manufacturer of Pradaxa is already involved in over 120 Pradaxa lawsuits. The lawsuits allege that Boehringer Ingelheim failed to warn doctors and patients about the risk of uncontrollable bleeding or hemorrhage because there currently is no medication to reverse Pradaxa in the event of over anti-coagulation or blood that is too thin. Here at the Beasley Firm, our dangerous drug lawyers have been accepting and preparing Pradaxa and bleeding lawsuits for many consumers who were injured by this unsafe medication.
Since 1958, The Philadelphia Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one had excessive bleeding, kidney failure, stroke, developed blood clots or a heart attack while on Pradaxa, please feel free to contact one of our lawyers, doctors or nurses for a strictly confidential and free consultation.
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