Navigation Links
New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA
Date:5/21/2012

MONDAY, May 21 (HealthDay News) -- The new blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found.

The review came in briefing documents that were filed Monday in advance of an FDA advisory panel meeting Wednesday, at which the panel is to vote on whether to recommend approval of Xarelto for treating people with acute coronary syndrome (a group of conditions brought on by sudden reduced blood flow to the heart).

The FDA is not required to follow the advice of its expert panels, but the agency typically does. A final decision is expected by the end of June, according to the documents.

Xarelto (rivaroxaban) is one of a new class of blood thinners that have been developed to overcome some of the problems that exist with the standard treatment, warfarin (Coumadin), which requires constant dose monitoring. Warfarin's effectiveness also can be altered by certain foods and other medications. Xarelto already is approved for use by those with atrial fibrillation (irregular heartbeat) and by people who are having hip- or knee-replacement surgery.

In the FDA briefing documents, an agency reviewer recommended approving the drug for treatment of acute coronary syndrome, mostly because trial data showed there was a reduction in cardiovascular death, even though there was also an increased risk of potentially fatal bleeding.

"However, what is not reflected in the sponsor's analysis are minor bleeding events," FDA reviewer Dr. Karen Hicks wrote in the briefing documents. "While it is true that these bleeding events typically do not lead to death or irreversible harm, these events may represent the biggest problem for both patients and health care providers if rivaroxaban is approved."

"While reductions in [cardiovascular] death still trump these bleeding events, if rivaroxaban is approved, we should expect a number of bleeding events that will require medical attention," Hicks wrote. "Carefully selecting patients for rivaroxaban therapy will be necessary to mitigate these bleeding risks."

In research presented at the American Stroke Association's International Stroke Conference in New Orleans last February, Australian doctors followed more than 14,000 people who took either Xarelto or warfarin for a median of two years. Of those patients, 136 had bleeding in the brain.

People who took Xarelto -- and suffered from the most common type of atrial fibrillation and didn't have heart valve damage -- were about one-third less likely to experience bleeding in the brain than those who took warfarin, the investigators found.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about stroke.

-- Randy Dotinga

SOURCES: May 21, 2012, briefing documents, U.S. Food and Drug Administration; February 9, 2012, news release, American Stroke Association


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Behavioral support from peers, staff lowers patients blood pressure
2. U.S. Task Force Issues Blood Pressure Guidelines
3. Women fare better than men, but need more blood after kidney cancer surgery
4. Fitness Fights High Blood Pressure, Even With Family History
5. Common Blood Pressure Drugs May Not Cut Colon Cancer Risk
6. Blood pressure drugs dont protect against colorectal cancer
7. Blood Clot Risk Linked to Some Non-Pill Contraceptives
8. T-Shirt, Gift Card Giveaways Raise Blood Drives Success
9. Cancer Cells in Bloodstream Show Great Diversity: Study
10. Procedure gives patients with A-fib who cant take blood thinners alternative to reduce stroke
11. Liver fat gets a wake-up call that maintains blood sugar levels
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA
(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 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: