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
'/>"/>

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

Page: 1 2

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:1/15/2014)... NEW YORK , Jan. 15, 2014 ... research report is available in its catalogue: ... - India Drug Forecast and Market Analysis ... PharmaPoint: Atopic Dermatitis - India ...
(Date:1/15/2014)...  Zafgen, Inc., a leading biopharmaceutical company dedicated to ... today announced initial results from its Phase 2a ... aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome ... results showed improvements in body weight, hunger-related behaviors, ...
(Date:1/14/2014)... North America,s leading business partnering event ... 30 th edition of its annual conference at the ... 21-24. (Logo: http://photos.prnewswire.com/prnh/20131028/NY05330LOGO-a ) ... specialty chemical companies will take part in the conference, which ...
Breaking Medicine Technology:PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2
... PALO ALTO, Calif., March 8, 2011 Jazz Pharmaceuticals, Inc. ... will be providing a business update at two upcoming investor ... financial officer, will provide an update at the ROTH 23rd ... Monday, March 14, 2011 at 4:30 p.m. Pacific Time ...
... Warner Chilcott plc (Nasdaq: WCRX ) ... its ordinary shares by certain selling shareholders. The selling ... Morgan Partners (advised by CCMP Capital) and Thomas H. ... management. The offering is being conducted as a public ...
Cached Medicine Technology:Warner Chilcott Announces Secondary Equity Offering 2Warner Chilcott Announces Secondary Equity Offering 3Warner Chilcott Announces Secondary Equity Offering 4
(Date:4/17/2014)... The presence of chronic inflammation in benign prostate ... cancer, and this association was found even in ... to a study published in Cancer Epidemiology, ... American Association for Cancer Research. , An analysis ... of the placebo arm of the Prostate Cancer ...
(Date:4/17/2014)... specifically associated with the risk of a difficult-to-diagnose ... of all breast cancer cases. , The largest ... invasive lobular carcinoma, gives researchers important clues to ... breast cancer, which can be missed through screening. ... journal PloS Genetics , was co-led by ...
(Date:4/17/2014)... popular vaccine brands for children may not be the ... cost factors when choosing vaccines, driving the market toward ... a new study by University of Illinois researchers. , ... by numerous factors," says Sheldon H. Jacobson, a co-author ... and of mathematics at the U. of I. "In ...
(Date:4/17/2014)... Biology and Medicine a multidisciplinary research team ... in the Institute of Genomic Biology (IGB) on ... describe their recent work on subcellular redox homeostasis. ... functions including energy metabolism, signaling, and transcriptional processes. ... cellular behavior, redox status has been recognized as ...
(Date:4/17/2014)... (April 17, 2014) Two recent papers by ... and colleagues may help scientists develop treatments or ... fever, Japanese encephalitis and other disease-causing flaviviruses. , ... and molecular genetics at the School of Medicine ... Hughes Medical Institute, and colleagues recently published articles ...
Breaking Medicine News(10 mins):Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 3Health News:Study recalculates costs of combination vaccines 2Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2Health News:CU researchers discover target for treating dengue fever 2
... ... implicate the purchaser in any lawsuit or cause such purchasers to be a party ... ... highly respected developer and manufacturer of proprietary skin care formulations, who also is the ...
... ... latest version of its revolutionary cost-cutting software. Newly developed upgrades to iCodeRx, iDocs, and ... processes, while providing the highest security possible to patient information. , ... Virginia Beach, VA (PRWEB) - DOMA ...
... ... a new agreement with B. E. Smith for Executive Leadership Solutions. , ... Lenexa, KS (Vocus) September 24, ... agreement with B. E. Smith for Executive Leadership Solutions., , ,Effective immediately, through August ...
... trials, advanced cancers shrunk rapidly, researchers say , THURSDAY, ... advanced melanoma promotes rapid shrinking of tumors, according to ... includes patients with the cancer-causing mutation of the BRAF ... melanomas and 5 percent of colorectal cancers. , The ...
... say , THURSDAY, Sept. 24 (HealthDay News) -- Surgery ... carpal tunnel syndrome who don,t have severe nerve damage ... 44 patients who had surgery and 52 patients who ... A year after treatment, the patients, hand function was ...
... drugs increase the possibility of septal malformation, researchers find ... who take certain antidepressants during the first three months ... giving birth to babies with heart defects. , Septal ... right side of the heart from the left -- ...
Cached Medicine News:Health News:Purchase PHYTO-C Skincare Will Not Implicate in the Lawsuit 2Health News:DOMA Transforms Healthcare IT with Increased Security While Reducing Cost -- iCodeRx/iDocs/iCharts 6.0 Debuts at AHIMA National Convention 2Health News:DOMA Transforms Healthcare IT with Increased Security While Reducing Cost -- iCodeRx/iDocs/iCharts 6.0 Debuts at AHIMA National Convention 3Health News:Members to Benefit from New Agreement between Amerinet and B. E. Smith 2Health News:New Treatment May Beat Melanoma 2Health News:New Treatment May Beat Melanoma 3Health News:Surgery Best for Carpal Tunnel Syndrome 2Health News:Surgery Best for Carpal Tunnel Syndrome 3Health News:Antidepressants Linked to Heart Defects in Newborns 2Health News:Antidepressants Linked to Heart Defects in Newborns 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: