Anticoagulants Approved for Deep Vein, Pulmonary Clots

Abstract

The oral anticoagulants apixaban and dabigatran have been approved for prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism. Apixaban's approval, for patients who have undergone hip or knee replacement surgery, was based on the results of three studies in more than 11,000 patients randomized to apixaban or enoxaparin, according to a statement from Bristol-Myers Squibb.Marketed as Eliquis, apixaban is a selective Factor Xa inhibitor, approved in 2012 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, at a recommended dose of 5 mg twice a day. The recommended dose for the new indication is 2.5 mg twice a day.The approved indications for dabigatran are the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.This also is the second approval for dabigatran, a direct thrombin inhibitor marketed as Pradaxa by Boehringer-Ingelheim Pharmaceuticals. It was approved in 2010 for the same atrial fibrillation indications that apixaban was, subsequently.Dabigatran's new approval was based on four international phase III studies, according to a statement issued by the company.The apixaban prescribing information includes a boxed warning about the increased risk of spinal or epidural hematoma, “which may cause long-term or permanent paralysis” in patients treated with apixaban who are undergoing spinal epidural anesthesia or spinal puncture.Dabigatran is approved with a medication guide, and the prescribing information includes a boxed warning about the increased risk of thrombotic events and spinal/epidural hematoma when it is prematurely discontinued.Serious adverse events associated with either drug should be reported to the Food and Drug Administration's MedWatch program at 800-332-1088 or www.fda.gov/medwatch. The oral anticoagulants apixaban and dabigatran have been approved for prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism. Apixaban's approval, for patients who have undergone hip or knee replacement surgery, was based on the results of three studies in more than 11,000 patients randomized to apixaban or enoxaparin, according to a statement from Bristol-Myers Squibb. Marketed as Eliquis, apixaban is a selective Factor Xa inhibitor, approved in 2012 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, at a recommended dose of 5 mg twice a day. The recommended dose for the new indication is 2.5 mg twice a day. The approved indications for dabigatran are the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrence of DVT and PE in patients who have been previously treated. This also is the second approval for dabigatran, a direct thrombin inhibitor marketed as Pradaxa by Boehringer-Ingelheim Pharmaceuticals. It was approved in 2010 for the same atrial fibrillation indications that apixaban was, subsequently. Dabigatran's new approval was based on four international phase III studies, according to a statement issued by the company. The apixaban prescribing information includes a boxed warning about the increased risk of spinal or epidural hematoma, “which may cause long-term or permanent paralysis” in patients treated with apixaban who are undergoing spinal epidural anesthesia or spinal puncture. Dabigatran is approved with a medication guide, and the prescribing information includes a boxed warning about the increased risk of thrombotic events and spinal/epidural hematoma when it is prematurely discontinued. Serious adverse events associated with either drug should be reported to the Food and Drug Administration's MedWatch program at 800-332-1088 or www.fda.gov/medwatch.