Navigation Links
FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
Date:10/19/2010

SILVER SPRING, Md., Oct. 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart's two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.

"People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Stockbridge says.

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating also were reported.

Pradaxa was approved with a Medication Guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.

For more information:

National Heart, Lung, and Blood Institute – What is Atrial Fibrillation?

http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Botox to Treat Chronic Migraine
2. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
3. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
4. FDA Approves Combination Contraceptive Containing a Folate
5. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
6. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
7. FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
8. FDA Approves Pediatric Use of Chemical Poisoning Treatment
9. FDA Approves Merz Pharmaceuticals Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
10. FDA Approves Vaccines for the 2010-2011 Influenza Season
11. FDA Approves Strativa Pharmaceuticals Zuplenz® (ondansetron) Oral Soluble Film
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... , Feb. 12, 2016  Eli Lilly and Company ... Court decided the Alimta® (pemetrexed disodium) vitamin regimen patent would ... the UK, France , Italy ... to dilute the product only with dextrose solution.  ... 2015, the UK Court of Appeal held that Lilly,s patent ...
(Date:2/12/2016)... 12 2016  OMS Supply, a large provider of ... announced today the recent launching of their new company ... of features that enhance the user experience and enable ... --> --> Despite ... company that started in early 2016, they have already ...
(Date:2/12/2016)... Feb. 12, 2016  Apellis Pharmaceuticals, Inc., ... $47.1 million Series D preferred stock financing, ... Hillhouse Capital Group and venBio Global Strategic ... AJU IB Investment, and Epidarex Capital. The proceeds ... further advance clinical trials in the Company,s ...
Breaking Medicine Technology:
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... ... School of Nursing with an in-kind gift of a VeinViewer® Vision vein ... as they learn how to start an IV and draw blood, combining technology ...
(Date:2/13/2016)... Montreal, Canada (PRWEB) , ... February 13, 2016 , ... ... best foot forward. They’ll groom themselves to perfection, go out of their way to ... their date – just take a look at any online dating profile. , ...
(Date:2/12/2016)... ... ... According to an article published February 4th on mySA, robotically ... hernia repairs throughout the United States. Commenting on this article, Beverly Hills hernia repair ... has not only been expected, but it seems to be a natural result of ...
(Date:2/12/2016)... ... ... The law firm of Morrow, Morrow, Ryan & Bassett is offering scholarships to ... to encourage applicants to pursue a degree in their field of study and upon ... “We have available jobs in St. Landry and Evangeline Parishes that can be filled ...
(Date:2/12/2016)... ... 12, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... at its 10th anniversary Fashion Luncheon on Monday, February 8, 2016. The special ...
Breaking Medicine News(10 mins):