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:10/12/2017)... 12, 2017   Divoti USA will engrave ... the standard of the latest FDA requirements, which stipulates new criteria ... Anyone in need of Medical ID jewelry such as Medical ID ... are engraved in terms of the new FDA requirements . ... Divoti offers this dark mark ...
(Date:10/11/2017)...  BioPharmX Corporation (NYSE MKT: BPMX) researchers were part ... way to use nonlinear optical imaging to confirm the ... A presentation ... how researchers from BioPharmX and the Wellman Center for ... suite of imaging techniques in what is called "Pharmacokinetic ...
(Date:10/11/2017)... 11, 2017  True Health, a leader in ... effort during National Breast Cancer Awareness month to ... Research recently ... that more than 10 million American women are ... BRCA1 or BRCA2 and have not had testing. These ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important to take ... an inventor from Austin, Texas, has identified a solution. , She developed a prototype ... restricted lighting. As such, it eliminates the need to turn on a light when ...
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton ... staged a mock evacuation of the facility as part of a disaster drill on ... Echo Hose EMS and Shelton City Emergency Manager, as well as the Connecticut ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of ... collection of specialty vendors and unique items from across the nation, this holiday-themed event ... wellness services offered by the VNA. The boutique will be open Saturday, November ...
Breaking Medicine News(10 mins):