Once-Daily Anticoagulant Xarelto Approved By FDA For DVT Prevention

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Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Blood / Hematology
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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

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Ofirmev (acetaminophen) Injection Approved For Pain And Fever By FDA

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Main Category: Pain / Anesthetics
Also Included In: Neurology / Neuroscience;  Bones / Orthopedics
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Intravenous Ofirmev (acetaminophen) has been approved by the Food and Drug Administration (FDA) for the management of mild to moderate pain, fever reduction, and the management of moderate to severe pain when in combination with opioid analgesics. Acetaminophen's international non-proprietary name is paracetamol.

President and CEO of Cadence Pharmaceuticals, the makers of Ofirmev, Ted Schroeder, said:

The approval of Ofirmev is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children. IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. With our planned launch early in the first quarter of 2011, we believe that Ofirmev will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting.

Acute pain - pain that comes on rapidly, may be severe, but is not long-lasting - especially post-operative pain, often requires at least two painkilling medications for effective pain relief. Acetaminophen is commonly prescribed, regularly in combination with oral opioids for pain management.

Cadence informs that clinical studies demonstrated that Ofirmev not only improved pain relief, but also reduced opioid consumption. The trials reported better patient satisfaction when Ofirmev formed part of a multi-modal regimen.

Director of Acute Pain Management at Thomas Jefferson University in Philadelphia, Eugene R. Viscusi, M.D., said:

Ofirmev is a long-awaited and much needed addition to postoperative pain management. With the approval of Ofirmev, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can't be used.

The Ofirmev trials included 1020 adults and 355 children - they were all administered IV (intravenous) acetaminophen. Two studies examined the safety and efficacy of Ofirmev in pain treatment, while another study evaluated Ofirmev for the treatment of fever.

Ofirmev 1000mg every six hours was significantly superior to a placebo in reducing pain intensity over a 24-hour period in patients undergoing hip/knee replacement surgery. In another study involving 244 patients who underwent abdominal laparoscopic surgery, either 1000mg of Ofirmev every six hours or 650mg every four hours, Ofirmev was considerably better in reducing pain intensity compared to a placebo over a 24-hour period.

A study involving adult participants who volunteered to be induced into a fever, demonstrated significantly superior results for those on Ofirmev 1000mg compared to those on a placebo. Symptom reduction was observed within 15 minutes of receiving the Ofirmev injection.

Cadence adds that clinical trials showed that Ofirmev was found to be well tolerated in a wide range of surgery types and patient types.

Regarding pediatric use, Cadence wrote in a communiqué:

The safety and effectiveness of OFIRMEV for the treatment of pain and fever in pediatric patients older than two years is supported by evidence from adequate and well controlled studies in adults and additional safety and pharmacokinetic data for this age group. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than two years of age.

Source: Cadence Pharmaceuticals

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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