Navigation Links
FDA Approves Blood Thinner Brilinta for Heart Patients
Date:7/20/2011

WEDNESDAY, July 20 (HealthDay News) -- In a long-awaited move, the U.S. Food and Drug Administration late Wednesday approved the blood thinner Brilinta (ticagrelor) for use in patients with acute coronary syndromes, to help lower their odds for heart attack and death.

Acute coronary syndromes include common conditions such as unstable angina or heart attack linked to lowered blood flow to the heart, the FDA noted in a statement. Brilinta, developed by pharmaceutical giant AstraZeneca, works to prevent new blood clots from forming.

The agency's move comes after a number of studies found that Brilinta performed well against the standard blood thinner now in use, Plavix (clopidogrel).

"In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily," Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

In approving Brilinta, the FDA is mandating a "boxed warning" on the drug's labeling, advising that taking the drug along with daily aspirin doses above 100 milligrams could decrease its effectiveness. The FDA is also mandating that AstraZeneca "conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin."

The boxed warning will also note that, as can happen with blood thinners generally, Brilinta may raise the odds for bleeding. According to the FDA, the most common side effects seen with Brilinta were bleeding and/or shortness of breath.

Late last month, a study presented at an American Heart Association press conference found that heart patients who took Brilinta with low-dose aspirin (less than 300 milligrams) had fewer cardiovascular complications than those taking Plavix plus low-dose aspirin. But, as the FDA noted in its approval, that benefit vanished when higher doses of aspirin were used.

Speaking at the time, Dr. Jeffrey S. Berger, assistant professor of medicine and director of cardiovascular thrombosis at NYU Langone Medical Center in New York City, said that "the study highlights that if one chooses to use ticagrelor in subjects with acute coronary syndromes, it would be logical to use aspirin 81 milligrams per day (and not 325 mg daily)."

He added that, "there is little reason to ever use aspirin 325 mg except in the acute setting of a heart attack or stroke. A higher aspirin dose (325 mg versus 81 mg) increases the risk of bleeding without increasing the efficacy of the drug."

More information

Find out more about preventing heart attack at the U.S. National Heart, Lung, and Blood Institute.

-- HealthDay Staff

SOURCES: U.S. Food and Drug Administration, news release, July 20, 2011; Jeffrey S. Berger, M.D., assistant professor, medicine and director, cardiovascular thrombosis, NYU Langone Medical Center, New York City


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

Related medicine news :

1. FDA Approves Test That Spots Aggressive Breast Cancer
2. FDA Approves Test That Spots HER2-Positive Breast Cancers
3. FDA Approves Another New Drug to Fight Hepatitis C
4. FDA approves new drug for advanced melanoma
5. FDA approves ipilimumab, an immunotherapy, to treat metastatic melanoma
6. FDA Approves 1st New Lupus Drug in More Than 50 Years
7. FDA Approves First 3D Mammogram Device
8. FDA Approves First Pacemaker Deemed Safe During MRIs
9. FDA Approves First Drug to Prevent Premature Births
10. Swiss agency approves clinical trial of UCI-created neural stem cell therapy
11. ACGME board approves final duty hour and supervision standards for resident education
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves Blood Thinner Brilinta for Heart Patients
(Date:10/13/2017)... EDWARDSVILLE, Ill. (PRWEB) , ... ... ... University Edwardsville School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and ... educated healthcare professionals on guideline updates for the primary prevention of cardiovascular ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for ... for action towards gender equality at their inaugural Summit in New York City in ... reached a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017 ... mobile health and big data solutions, today announced that its MyDario product ... check your local TV listings for when The Dr. Oz Show airs ... The ... this month. ...
(Date:9/22/2017)... -- As the latest Obamacare repeal effort moves is debated, ... and Lindsey Graham (R-SC) medical device market ... is in an odd place.  The industry wants repeal ... on medical device sales passed along with the Affordable ... visits and hospital customers with the funding to invest ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 ... , and OptiMed Specialty Pharmacy of Kalamazoo, ... offer a strategic hub service that expedites and streamlines ... personal spirometer, Spiro PD 2.0, and wellness management services.  ... is a medical device used to measure lung function ...
Breaking Medicine Technology: