Pradaxa® may be more likely to cause life threatening bleeding than other drugs for this same purpose.
Pradaxa®, manufactured by Boehringer Ingelheim Pharmaceuticals, was first approved by the FDA on October 29, 2010 for the treatment of people with atrial fibrillation, or an irregular heartbeat. This anticoagulant (blood thinning drug) is prescribed to lower the risk of blood clots that could result in a stroke. Doctors wrote more than 3.7 million prescriptions for this new blood thinner after the FDA approved it in October 2010. Pradaxa® has the usual side effects and health risks of other blood thinners, which include excessive bleeding. However Pradaxa® has two important differences 1) there is no known reversal agent or antidote; and 2) there is no standard method with which to measure the anticoagulant effects. A 2011 FDA Safety Communication stated that Pradaxa® may be more likely to cause life threatening bleeding than other drugs for this same purpose.