Pradaxa (Dabigatran) is an oral anticoagulant prescribed to lower the chance of stroke for those suffering from atrial fibrillation (not caused by heart valve issues) and to treat blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again. Pradaxa was introduced in the U.S. market in 2010, as an alternative to warfarin, after gaining an approval from the U.S. Food and Drug Administration (FDA). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingelheim Pharmaceuticals, Inc.
Pradaxa is known as a "direct thrombin inhibitor," which lowers the chance of blood clots forming in the body by blocking thrombin - the blood's central clotting agent, thereby preventing nonhemorrhagic strokes and embolic events. It comes in 75 mg, 110 mg, and 150 mg capsules.
Within a year of introduction, adverse event reports of patients suffering from hemorrhaging, dyspepsia (abdominal pain, impaired digestion), gastrointestinal hemorrhaging and brain bleeding were received. When introduced, Pradaxa had no antidote; therefore, there was no way to control bleeding unlike Vitamin K used to reverse the effect of competitor warfarin.
In October 2015, the FDA granted an accelerated approval to Praxbind (idarucizumab), to allow doctors to reverse Pradaxa’s blood-thinning effects in emergency situations when bleeding can’t be controlled.