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:12/7/2016)... -- Global Cervical Dysplasia Market: Scope and Methodology ... market analyzes the current and future prospects of ... summary, including a market snapshot that provides overall ... research is a combination of primary and secondary ... research efforts along with information collected from telephonic ...
(Date:12/7/2016)... -- Research and Markets has announced the addition of ... Forecast to 2021" report to their offering. ... , , The immunohistochemistry ... at a CAGR of 7.3% during the forecast period of 2016 to ... and rapidly increasing geriatric population across the globe are the primary driving ...
(Date:12/7/2016)... , Dec. 7, 2016  Palatin Technologies, Inc. ... closed on a previously disclosed underwritten public offering ... Genuity acted as sole book-running manager, Roth Capital ... Markets acted as co-manager for the offering. ... million in net proceeds, allowing us to continue ...
Breaking Medicine Technology:
(Date:12/7/2016)... New York, NY (PRWEB) , ... December 07, ... ... measurable amounts of the drug in their bodies, a researcher at the Icahn ... the journal Pediatric Research. , The study found that when young children are ...
(Date:12/7/2016)... LAKE CITY, UTAH (PRWEB) , ... December 07, ... ... productivity, today announced the release of Smart Device Remote Control through a new ... management across all platforms and strengthens its mobile solutions to help businesses maximize ...
(Date:12/7/2016)... ... December 07, 2016 , ... EnghouseSystems ... purchase price of approximately $17.4 million (net of the cash acquired), subject ... $13.2 million. Headquartered in Barcelona, Spain, Presence is a leading provider of ...
(Date:12/7/2016)... , ... December 07, 2016 , ... It is vital ... is with useful, properly analyzed data. The team at Beckman Coulter has designed Kaluza, ... 'need for speed' and the need to operate in a GLP (Good Laboratory Practice) ...
(Date:12/7/2016)... ... December 07, 2016 , ... A quote from Dr. Edward Hallowell, ... on social media that offer a rare glimpse into the mind of those people ... New York Times bestselling author, has described people with ADHD as having “Ferrari engines ...
Breaking Medicine News(10 mins):