Pradaxa (Dabigatran) is the “new kid on the block” prescription drug used in the treatment of heart valve problems or atrial fibrillation in those who have an elevated risk of stroke. Pradaxa (Dabigatran) was given the FDA green light a little over two years ago, appearing to be a good solution to these particular medical issues. Pradaxa (Dabigatran) manufacturer, Boehringer Ingelheim claims Pradaxa (Dabigatran) is at least 35% better at reducing the risk of stroke than its predecessor, Warfarin—also known as Coumadin. Warfarin has basically been the only drug of its kind on the market for the past half a century until Pradaxa (Dabigatran) came on the scene. The kidneys are responsible for flushing out excess Pradaxa (Dabigatran) from the body therefore in those whose kidney functions are less than optimal, bleeding problems can occur, and it appears from the number of adverse reports sent to the FDA there are other potentially serious side effects.
The initial FDA approval was granted largely on a RE-LY study of over 18,000 patients which showed Pradaxa (Dabigatran) effectively reduced the risk of stroke and embolisms by 35% more than Warfarin. Unfortunately, less than six months following the FDA’s approval of Pradaxa (Dabigatran), the manufacturer reported that as many as 250 deaths were possibly tied to use of the drug while the FDA had received over 900 reports of serious side effects and over 100 deaths. January, 2012 saw a new study’s published findings which suggests that an increased risk of heart disease or heart attack are possible in those taking Pradaxa (Dabigatran) when compared with those taking Warfarin.
Many of those who are taking Pradaxa (Dabigatran) will have minor side effects such as diarrhea, heartburn, nausea, mild to moderate stomach pain or stomach upset or indigestion. More serious side effects include a general feeling of exhaustion or lethargy or bruising which is unusual and continues to worsen. Dizziness or headaches which are worse than a normal headache and come on suddenly are cause for concern when taking Pradaxa (Dabigatran). Any swelling or weakness in the limbs or in the joints can be a serious side effect of Pradaxa (Dabigatran) as is bleeding from the gums or nose and coughing up or vomiting blood. Urine which appears brown or pink or red, black or tarry stools are also potentially serious side effects from Pradaxa (Dabigatran). Any type of unusually heavy bleeding including a particularly heavy menstrual period should be evaluated by your physician.
The side effects which can lead to death include intra-articular or pericardial bleeding, intracranial hemorrhage, hemorrhagic stroke or other subdural bleeds. Pradaxa (Dabigatran) and Warfarin, though the same category of drugs, work differently to alleviate the risk of stroke. Pradaxa (Dabigatran) is a thrombin or blood clot inhibitor which stops clots from forming while warfarin is a vitamin K antagonist which helps prevent clots from forming by interfering with the body’s production of vitamin K—a known clotting agent. Because there is no known reversal agent for Pradaxa (Dabigatran) and no accepted method of measuring the anticoagulant effect of the drug, bleeding can occur so quickly and so severely, that death soon follows. Although no official recall has been issued by either the manufacturer of Pradaxa (Dabigatran) or the FDA you should discuss the potential risks with your physician, and seek medical attention immediately should any of the above symptoms manifest. If you have suffered harm from Pradaxa (Dabigatran) you should seek the services of a highly qualified personal injury attorney and get more information.
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