Navigation Links
FDA Panel Backs New Anti-Clotting Drug
Date:3/19/2009

Rivaroxaban could replace heparin after hip- or knee-replacement surgery ,,,,

THURSDAY, March 19 (HealthDay News) -- The benefits of the experimental blood-thinning drug rivaroxaban outweigh its risks, a U.S. Food and Drug Administration advisory panel said Thursday.

Rivaroxaban (Xarelto) could be one of the long-sought alternatives to commonly used blood thinners, particularly for hip- and knee-replacement patients.

The panel voted 15 to 2 in favor of the Johnson & Johnson product, despite risks of internal bleeding associated with it. Although the FDA is not bound by its advisory panels' recommendations, it typically follows them.

The drug was more effective at reducing potentially fatal blood clots than heparin, a widely used blood thinner, with no increase in side effects, according to studies by three research teams, whose papers were published in June in the New England Journal of Medicine and The Lancet.

Heparin is commonly used in hospitals, because it is easier to manage than Coumadin (warfarin), which requires frequent blood tests for close control. Rivaroxaban is a pill that does not require constant monitoring.

Johnson & Johnson and its partner Bayer are asking the FDA to approve rivaroxaban for use in patients who have had hip or knee replacements. The once-a-day pill could prevent clots from forming and traveling to the lungs. Clots are a common side effect after these replacement procedures.

The FDA is scheduled to make a decision on rivaroxaban by May 28, according to the Associated Press. If approved, the drug would be the first oral anticoagulant drug approved since the FDA approved warfarin in 1954, according to Dow Jones.

Johnson & Johnson reacted positively to the panel's recommendation.

"We appreciate the thoroughness of the advisory committee's review, and we will continue to work with the FDA as they finalize their review," Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

More information

For more on anti-clotting drugs, visit the American Heart Association.



SOURCES: March 19, 2009, news release, Johnson & Johnson; Associated Press; Dow Jones


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... Hills Estates, CA (PRWEB) , ... January 24, 2017 , ... ... performance at studies, work, athletics or even in relationships. Course offered by Dr. ... fee is necessary due to limited seating and the many hands-on experiences. ...
(Date:1/24/2017)... ... January 24, 2017 , ... West’s Health ... annual Solutions Series of webinars will start January 31 with a session about ... of current health and benefits topics, including employee engagement, pricing transparency, population health ...
(Date:1/24/2017)... TX (PRWEB) , ... January 24, 2017 , ... Bellus ... the company’s team of medical experts. In his new role Dr. Dobke will provide ... , Dr. Dobke is the Head of Plastic Surgery and Associate Professor of ...
(Date:1/24/2017)... Chapel Hill, N.C. (PRWEB) , ... January 24, ... ... the Trump Administration is the focus of a new report from the ... Carolina Kenan-Flagler Business School. , Influential business leaders, academics and policy makers identified ...
(Date:1/24/2017)... (PRWEB) , ... January 24, 2017 , ... The results ... news for everyone and particularly good news for prostate cancer patients: incidents of cancer ... , According to the report the cancer death rate has dropped from its peak ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... -- In a major study released this weekend from ... 1 ( http://www.multivu.com/players/English/7899551-nephrocheck-test-acute-kidney-injury-outcomes/ ), Astute Medical,s ... patients at high risk of Acute Kidney Injury ... control trial led by Alexander Zarbock , ... standard of care or a treatment per Kidney ...
(Date:1/24/2017)... , Jan. 24, 2017 Market Research Future has a half ... Wound Closure Device is growing rapidly and expected to continue its growth ... ... CAGR of 5% from 2013 to 2019 and reaching a value of ... forecasted period, 2016-2022 Global Wound Closure Device Market has been ...
(Date:1/24/2017)... Jan. 24, 2017  The Orthopaedic Implant Company ... high-value orthopaedic implants, announced the launch of its ... The OIC Tibial Nail System is designed ... proximal and distal screw holes accommodate varying fracture ... dynamization.  The nail is available in diameters of ...
Breaking Medicine Technology: