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:10/13/2017)... LEXINGTON, Ky. (PRWEB) , ... October 13, 2017 , ... ... MD, MPH to become its next President and Chief Executive Officer, succeeding Dr. James ... and CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and ... explains one of the most popular and least understood books in the Holy Scriptures, ... puzzling descriptions that have baffled scholars for centuries. Many have tossed it off as ...
(Date:10/12/2017)... WILMINGTON, Del. (PRWEB) , ... October 12, 2017 ... ... technology and advisory services for healthcare compliance program management, will showcase a range ... and National Association for Assisted Living (NCAL) Convention and Expo to be held ...
(Date:10/12/2017)... , ... October 12, 2017 , ... The American College ... to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in ... , In honor of Morris F. Collen, a pioneer in the field of medical ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017  PMD ... OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... strategic hub service that expedites and streamlines patient and ... Spiro PD 2.0, and wellness management services.  ... medical device used to measure lung function for a ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has been ... Atlanta Football Host Committee (AFHC) for the 2018 College Football ... 8, 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... the AFHC "I,m In" campaign, participating in many activities leading ... ...
(Date:9/12/2017)... N.J. , Sept. 12, 2017  Consumer reviews on the ... Hearing as the number one company for hearing aids, ranking ... and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high ...
Breaking Medicine Technology: