Knee or hip replacement surgery: FDA has approved Xarelto to reduce risk of blood clots


The FDA ( Food and Drug Administration ) has approved Xarelto ( Rivaroxaban ) to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.

Xarelto is a pill taken once daily. Those undergoing a knee replacement should take the medication for 12 days and patients undergoing a hip replacement procedure should take Xarelto for 35 days.

The safety and effectiveness of Xarelto was evaluated in patients undergoing hip replacement surgery and patients undergoing knee replacement surgery. Clinical studies were designed to identify occurrence of venous thromboembolic events, deep vein thrombosis, pulmonary embolism or death in patients treated. Treatment with Xarelto was compared to treatment with enoxaparin, a drug that prevents deep vein thrombosis or blood clotting.

More than 6,000 patients undergoing hip or knee replacement surgery received Xarelto in clinical studies. Among patients undergoing knee replacement surgery, 9.7% of those treated with Xarelto had venous thromboembolic events compared with 18.8% of patients who received Enoxaparin.

In a study involving hip replacement surgery, 1.1% of patients who received Xarelto had venous thromboembolic events compared with 3.9% of those who received Enoxaparin.

In another study of hip replacement patients, 2.0% of those treated with Xarelto had venous thromboembolic events compared with 8.4% of those who received Enoxaparin.

The most common side effect observed in patients treated with Xarelto was bleeding.

Other FDA approved drugs to prevent blood clotting include Lovenox ( Enoxaparin ), generic versions of Enoxaparin, Arixtra ( Fondaparinux ), Fragmin ( Dalteparin ) for hip replacement surgery only, Coumadin ( Warfarin ) and Heparin.

Source FDA, 2011

XagenaMedicine2011