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Ohio Pradaxa News
On October 19, 2010, the FDA approved Pradaxa (dabigatran etexilate mesylate), an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. Pradaxa, is manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn. Boehringer Ingleheim’s parent company is a German corporation, with a presence in countries all around the world.
Pradaxa is the first oral blood thinner on the market in over 50 years. Coumadin (warfarin), the other oral anticoagulant currently on the market, has been approved since the early 1950s. Pradaxa is used to prevent strokes and blood clots (deep vein thrombus, pulmonary emboli, and cardiac thrombi) in people with atrial fibrillation.
On December 7, 2011, the FDA issued a safety announcement that it was evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa. On February 1, 2012, a New Zealand study was published in the Journal of the American College of Cardiology, which found that Pradaxa has a higher risk of bleeding than its alternative, Coumadin (warfarin). The authors of the study are a group of hematologists from New Zealand who treated what they believed was a large cluster of patients who had suffered serious bleeding after using Pradaxa. In two months, there had been 78 bleeding episodes, including 12 major bleeds, one of which may have caused a patient’s death.
There is no reversal agent for Pradaxa. When patients suffer bleeding, doctors have been unable to stop the bleeding because Pradaxa prevents blood from clotting. Coumadin (warfarin), the alternative to Pradaxa, can be reversed with a simple dose of Vitamin K. Unlike warfarin, Pradaxa has no antidote. if you are a caregive for a senior you must watch them carefully if they are on pradaxa. Contact the pradaxa helpline for a Pradaxa lawsuit for fatalities form pradaxa