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:5/3/2016)... ... May 03, 2016 , ... Elizabeth Murray has always loved ... join her with one on her shoulder and one on her arm. But she ... because of years of mitral valve prolapse. , The valves of the heart wouldn’t ...
(Date:5/3/2016)... ... May 03, 2016 , ... ... university, has announced today the launch of its Associates and Bachelor's degrees in ... Emeritus of The Rockefeller University, Dr. Torsten N. Wiesel; Chairman and CEO of ...
(Date:5/3/2016)... ... May 03, 2016 , ... Boston Children’s Hospital today announced its new pediatric ... practice tricky or rare procedures in an environment that looks and feels real. , ... available to inventors and “hackers” to develop and test new devices or software platforms ...
(Date:5/3/2016)... ... May 03, 2016 , ... Park Cities Pet Sitter has ... adjacent to the 75204, 75205, 75206, 75209, 75219, 75220, 75225, 75229, 75230, 75231 and ... Midway Hollow, North Dallas, Plano, Preston Hollow and Park Cities areas of the Metroplex. ...
(Date:5/3/2016)... ... May 03, 2016 , ... Intrigma, the leading provider of ... is expanding its use of Intrigma’s cloud-based physician scheduling solution, Efficient Scheduler (a ... concept. The Portland, Oregon based health system conducted a one-year pilot of the ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... April 28, 2016 ... George Phillips und Stephen Schmidt ... ArisGlobal®, ein führender Anbieter cloudbasierter ... heute bekannt, dass neue Führungskräfte zum Team ... sind, die vielfältige Erfahrungen mitbringen.  Dies wird ...
(Date:4/28/2016)... 28, 2016 , Net Sales of $1.90 ... over the prior year period, and an increase of 1.2% ... Diluted EPS for the first quarter were $0.52 reported, a ... adjusted, an increase of 29.9% over the prior year period ... earnings guidance for 2016 Zimmer Biomet Holdings, Inc. ...
(Date:4/28/2016)... N.J. , April 28, 2016   Acsis ... today announced that leading IT market research and advisory ... " in the IDC MarketScape: Worldwide Pharmaceutical Track and ... 2016).  The report provides an assessment of the capabilities ... track and trace software market. Logo - ...
Breaking Medicine Technology: