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FDA APPROVES NEW BLOOD THINNER FOR HIP AND KNEE REPLACEMENT PATIENTS

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On July 1, the Food and Drug Administration approved Xarelto® (Rivaroxaban tablets, Janssen Pharmaceuticals, Inc.), an anticoagulant drug to prevent deep vein thrombosis (DVT), for patients undergoing knee and hip-replacement surgery.

With aging baby boomers, joint replacement surgery is becoming more common. Orthopedic surgeons performed about 520,000 hip replacements and about 581,000 knee replacements in 2006.

Randy Fenninger, President of the National Blood Clot Alliance (NBCA) said that “blood thinners are safe and effective in preventing blood clots and this new tablet blood thinner offers a new option for preventing blood clots in patients undergoing hip or knee replacement surgery.  The NBCA encourages people to discuss the risk of blood clots and which blood thinner offers optimal protection with their physicians as part of their pre-surgical consultation.”

Richard Freidman, MD, and member of NBCA’s Medical and Scientific Advisory Board said “I think the new oral agents will lead to a paradigm shift in the way orthopedic surgeons handle blood clot prevention in their patients, resulting in a greater awareness for both patients and physicians and improved patient care.” (Dr.Friedman is Clinical Professor of Orthopaedic Surgery at the Medical University of South Carolina).

Alan Brownstein, NBCA CEO said that “DVTs can travel to the lungs leading to life threatening Pulmonary Embolisms (PE)” and that he hopes “that this new drug will focus attention on the need to prevent blood clots in hip and knee patients.”

NBCA recently conducted a national survey of DVT /PE awareness among hip and knee patients and hip and knee surgeons. The results, reported in May 2011, found major gaps in awareness among patients and therapeutic barriers perceived by surgeons which impact their use of anticoagulation therapies in the prevention DVT/PE. Despite evidence-based guidelines, DVT/PE prevention practices vary widely, according to survey results. Follow the link for survey findings, fact sheet, poster and DVD–  http://www.stoptheclot.org/News/article265.htm.

Brownstein said “these survey findings validate the need for interventions to address anticoagulant treatment barriers, and the need to better define optimal DVT/PE prophylaxis for hip/knee replacement patients to overcome longstanding therapeutic obstacles.”

NBCA is sharing additional results of its DVT/PE Awareness Survey findings at additional medical meetings in upcoming weeks and months, and through educational DVDs being made available to healthcare professionals in orthopedics nationwide. For more information, or to order free copies of the NBCA DVT/PE Awareness Survey DVD, contact NBCA at http://www.stoptheclot.org or 877.4No.Clot (877-466-2568).

NBCA is a patient-led advocacy organization dedicated to promoting patient and public awareness about the signs and symptoms of DVT and PE.

Janssen Pharmaceuticals, Inc. issued a release concerning FDA’s approval http://www.sacbee.com/2011/07/01/3741884/fda-approves-xarelto-rivaroxaban.html

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