The labeling of dabigatran etexilate (Pradaxa – Boehringer Ingelheim), an oral direct thrombin inhibitor, has recently been updated to include new dosing and monitoring recommendations and a warning on the risk of bleeding. Dabigatran etexilate was approved in the US in 2010 for the prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been shown to be more effective than warfarin (Coumadin, and others) for this indication.

The results of a recently published study suggest that taking the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) with either simvastatin (Zocor, and others) or lovastatin (Altoprev, and others) increases the risk of major hemorrhage.

The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.

The FDA has approved idarucizumab (Praxbind – Boehringer Ingelheim) for urgent reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Idarucizumab is the first specific reversal agent to become available for one of the new oral anticoagulants.

Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one or more of the following: congestive heart failure, hypertension, age ≥75 years, diabetes, or prior stroke or transient ischemic attack (CHADS₂ score ≥1).

Anticoagulants are the drugs of choice for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE).

Full-page newspaper advertisements and a series of television commercials have urged patients with atrial fibrillation to "rethink warfarin" in favor of Eliquis (apixaban – Bristol-Myers Squibb). Apixaban is the latest of 3 new oral anticoagulants now competing with warfarin (Coumadin, and others) for the oral anticoagulant market.

The FDA has approved apixaban (Eliquis – Bristol-Myers Squibb/Pfizer), an oral direct factor Xa inhibitor, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the third new oral anticoagulant to be approved for this indication as an alternative to warfarin.

Direct-to-consumer advertisements continue to urge patients who take warfarin (Coumadin, and others) for atrial fibrillation to ask their doctors about the benefits of one or another of the newer oral anticoagulants.

The FDA has approved use of Kcentra (CSL Behring), a human-derived 4-factor prothrombin complex concentrate (PCC), for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. It is the only 4-factor PCC available in the US.