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:4/22/2017)... ... April 22, 2017 , ... ... as Vice President of Sales and Business Development at OAKWORKS, Inc. Mr. ... engagements, business development, and strategic planning for the company. Recognized industry-wide as ...
(Date:4/21/2017)... (PRWEB) , ... April 21, 2017 , ... An April ... of a pair of ancient teeth, which reveal a great deal about prehistoric ice-age ... a sharp stone may have been used to remove decayed dental matter, and that ...
(Date:4/21/2017)... ... April 21, 2017 , ... The staff at Palm Beach Face is proud to ... in the 2017 London Marathon. Set to take place on April 23rd, the London Marathon ... Dr. Schwartz will run as part of team EMPOWER, raising money for the international charity, ...
(Date:4/21/2017)... , ... April 21, 2017 , ... Chicago plastic surgeon, ... removal of osteoma. An osteoma is a benign bony lump located on the forehead ... and can cause difficulties with sight and pain. Dr. Shah has discovered an approach ...
(Date:4/21/2017)... Wis. (PRWEB) , ... April 21, 2017 , ... ... today announced that its B-595 and B-7569 vinyl label materials ... identification and warning labels are tested to remain intact and legible, for use on ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... ZappRx, Inc ., a digital health company focused on modernizing ... closed $25 million in Series B funding led by Qiming ... Seattle that is part of a broader ... round included participation from SR One , who led ... (formerly Google Ventures). As part of the financing, Mark ...
(Date:4/20/2017)... , April 20, 2017 Research and ... Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, ... report to their offering. ... The global pharmacogenomics market was valued at US$ 7,167.6 Mn ... by 2024, expanding at a CAGR of 5.6% from 2016 ...
(Date:4/20/2017)... , April 20, 2017 NeuroVive Pharmaceutical ... today announced positive preclinical results demonstrating anti-fibrotic ... for non-alcoholic steatohepatitis (NASH), in an additional ... NV556 has previously shown similar anti-fibrotic ... Today, NeuroVive,s scientists present novel data demonstrating ...
Breaking Medicine Technology: