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:5/26/2016)... , ... May 26, 2016 , ... ... intellectual property (IP) to its specialty academic programs. , Answering to the increasing ... existing certificate programs in health law, and environmental and land use law. , ...
(Date:5/26/2016)... ... 2016 , ... Cardiac arrhythmia is a common complication following ... survival, reports a team of UPMC researchers in the largest study of its ... Thoracic and Cardiovascular Surgery, provide critical information that will hopefully lead to better ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will ... Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public ... Retina Group of New York , is a Board Certified ophthalmologist who ...
(Date:5/26/2016)... ... 2016 , ... Leadership of Life Science Logistics (LSL), a ... earned its ISO 13485 certification, indicating the company’s quality control system for medical ... associated with ISO quality standard 13485. , BSI Group America, Inc., a ...
(Date:5/26/2016)... ... May 26, 2016 , ... Nike Yoga Camps ... from daily practices, arts & crafts, discussions, and games all geared towards enhancing ... Evans have combined backgrounds in kids’ yoga, collegiate sport yoga instruction, and global ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... , May 25,2016 FDA ... near-infrared Cellvizio platform for urological and surgical applications ... MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser ... milestone in the US with the 12 th ... Drug Administration (FDA). This new FDA clearance covers ...
(Date:5/25/2016)... , Germany and GERMANTOWN, ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime Standard: ... licensing and co-development agreement with Therawis Diagnostics GmbH to develop ... be to develop and market PITX2 as a marker to ... high-risk breast cancer patients. "We are pleased to ...
(Date:5/25/2016)... -- According to market research "Global Insulin ... Forecast to 2022 - Industry Insights by Type (Insulin ... P&S Market Research, the global insulin delivery device market ... is expected to grow at a CAGR of 6.6% ... is expected to witness the fastest growth at a ...
Breaking Medicine Technology: