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FDA NEWS RELEASE

For Immediate Release: July 5, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements

On July 1, the U.S. Food and Drug Administration approved Xarelto (rivaroxaban) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) 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 (VTE), DVT, PE or death in patients treated. Treatment with Xarelto was compared to treatment with enoxaparin, a drug that prevents DVTs or blood clotting.

“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.

More than 6,000 patients undergoing hip or knee replacement surgery received Xarelto in clinical studies. Among patients undergoing knee replacement surgery, 9.7 percent of those treated with Xarelto had VTE compared with 18.8 percent of patients who received enoxaparin. In a study involving hip replacement surgery, 1.1 percent of patients who received Xarelto had VTE compared with 3.9 percent of those who received enoxaparin. In another study of hip replacement patients, 2.0 percent of those treated with Xarelto had VTE compared with 8.4 percent 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.

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 information:

FDA: Office of Oncology Drug Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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