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:10/12/2017)... ... , ... The American College of Medical Informatics (ACMI) will present the 2017 ... Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is ... pioneer in the field of medical informatics, this prestigious award is presented to an ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... the nation's first interactive health literacy software tool, and the Cancer Patient Education ... of cancer patient education, today announce a new strategic alliance. , As ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... Oct. 4, 2017 OBP Medical ... illuminating medical devices, today announced regulatory approval from ... Agency (or Agência Nacional de Vigilância Sanitária (ANVISA)) ... cordless surgical retractor with integrated LED light source ... illumination and exposure of a tissue pocket or ...
(Date:10/2/2017)... , Oct. 2, 2017 Halo Labs announces the European ... system called the HORIZON at MIBio 2017 in Cambridge, ... and visible particulate matter in biopharmaceutical samples with unprecedented speed and ... the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
(Date:9/27/2017)... MIAMI , Sept. 27, 2017  Commended for their ... recent notable awards. Ranked as number one in the South ... ninth time in Inc. 5000 yearly list, the national specialty ... CEO, Armando Bardisa will soon be honored by ... Set to receive his award ...
Breaking Medicine Technology: