Once-Daily Anticoagulant Xarelto Approved By FDA For DVT Prevention

Editor's Choice
Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Blood / Hematology
Article Date: 02 Jul 2011 - 9:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }()); email to a friend   printer friendly   opinions  

Blood thinner (anticoagulant) Xarelto (rivaroxaban tablets) has been approved by the FDA (Food and Drug Administration) for the prevention of DVT (deep vein thrombosis) in patients who had knee or hip replacement surgery. The tablets are taken once daily.

According to Xarelto makers, Janssen Pharmaceuticals, Inc., about 80,000 patients in the USA undergo hip or knee replacement surgery every year, the majority of them are aged 50+ years and suffer from arthritis. They have a significantly higher risk of DVT.

Deep Vein Thrombosis, also known as DVT occurs when a blood clot develops in a large vein, generally in the arm or leg. Blood circulation becomes either partially or completely blocked. There is a risk the clot becomes dislodged and travels along the bloodstream into the lungs, creating a potentially fatal condition known as pulmonary embolism (PE).

PE and DVT are the main reasons patients who underwent joint replacement surgery have to be re-hospitalized.

Patients should be given anticoagulants (blood thinners) after major orthopedic replacement surgery, the American College of Chest Physicians recommends. They should be given immediately after surgery and also for up to 10 days for knee replacement and 35 days for hip replacement.

Human studies demonstrated Xarelto's clinical benefits when it was compared to Lovenox (enoxaparin), the most widely used medication today. Xarelto has been approved by regulatory authorities in over 100 countries for venous thromboembolism prevention in orthopedic replacement surgery.

Xarelto is a joint venture by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. and Bayer Health Care.

Louis M. Kwong, M.D., Professor of Orthopedic Surgery at Harbor-UCLA Medical Center, who was involved with the rivaroxaban clinical trials program, said:

"The approval of once-daily XARELTO® tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery. XARELTO® has a proven clinical benefit over one of today's most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice."

Alan Brownstein, Chief Executive Officer of the National Blood Clot Alliance, said:

"The use of blood thinners has been shown to safely and effectively help keep people from developing preventable blood clots. The FDA approval of a new blood thinner, XARELTO®, offers a new option for patients seeking knee or hip replacement surgery, and we encourage people to discuss with their physicians the risk of blood clots and which blood thinner offers optimal protection as part of their pre-surgical consultation."

Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc., said:

"Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and XARELTO® provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home. We're pleased to make XARELTO® tablets available to physicians to help them better protect their patients from these highly preventable surgical complications."

Janssen Pharmaceuticals, Inc. is pharmaceutical company of Johnson & Johnson.

Written by Christian Nordqvist

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Privacy Policy | Terms and Conditions

MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2011 All rights reserved.

View the original article here