Look Out Coumadin, Something Better is Finally Here

 Late Tuesday, Boehringer Ingelheim announced that the US FDA has approved dabigatran (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

The drug will be available in two doses: 150 mg twice daily and, for a small subset with severe renal impairment, 75 mg twice daily. Debates about the approved dosing have already begun

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," the director of the FDA's Division of Cardiovascular and Renal Products said in an FDA news release.

The drug, a direct thrombin inhibitor, will come with a medication guide to warn patients of the potential for serious bleeding. Other side effects include gastrointestinal symptoms.

No more INR checks! No more alternating dosages. One pill, one dose, no monitoring. Management of atrial fibrillation in this country is about to change.