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Xarelto Approved by FDA to Reduce Risk of DVT with Surgery


Xarelto (rivaroxaban) was approved by the U.S. Food and Drug Administration on July 1, 2011 to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.

DVT is a serious medical condition that occurs when a blood clot (thrombus) forms in one of the large veins, usually in the lower limbs, leading to either partially or completely blocked circulation. DVT may result in a pulmonary embolism (PE) if the blood clot travels from where it formed to the lungs. This can result in death if not diagnosed and treated effectively.

DVT occurs in approximately 2 million Americans each year. Pulmonary embolism kills up to 300,000 people a year in the U.S.

DVT can occur in almost anyone, but certain individuals may be at increased risk for developing a DVT. Risk factors for DVT include surgery, decreased mobility, cancer, increased age (over 40 years), obesity, smoking, and a personal or family history of venous thromboembolism (VTE).

Orthopedic surgery patients, especially hip and knee, are at risk of DVT. Prevention is important.

Xarelto is a pill taken once daily rather than injection. 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 more than 6,000 patients undergoing hip or knee replacement surgery. The clinical studies were designed to identify occurrence of venous thromboembolic events (VTE), DVT, PE or death in patients treated. Treatment with Xarelto was compared to treatment with enoxaparin (Lovenox), a drug given by injection that prevents DVTs or blood clotting.

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Among patients undergoing knee replacement surgery, 9.7% of those treated with Xarelto had VTE compared with 18.8% of patients who received enoxaparin. In a study involving hip replacement surgery, 1.1% of patients who received Xarelto had VTE compared with 3.9% of those who received enoxaparin. In another study of hip replacement patients, 2.0% of those treated with Xarelto had VTE compared with 8.4% of those who received enoxaparin.

“Xarelto represents a new oral treatment option to help prevent blood clotting in patients receiving a hip or knee replacement,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. Xarelto was reviewed by the Division of Hematology Products within the Office of Oncology Drug Products.

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.

Symptoms of DVT may include pain, swelling, tenderness, discoloration or redness of the affected area, and skin that is warm to the touch. These symptoms are similar to those of other conditions such as infections and phlebitis which can make DVT difficult to diagnose at times.

Symptoms of PE include unexplained shortness of breath, chest pain, rapid heart rate, unexplained coughing, and coughing up blood. It is important to seek immediate medical attention if you have any of these symptoms.

Xarelto is marketed in the U.S. by Raritan, N.J.- based Janssen Pharmaceuticals, Inc., a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.

For more important information about reducing the risk of DVT, go to www.preventdvt.org.

Food and Drug Administration