Pradaxa (dabigatran etexilate mesylate) is a blood thinning medication used to reduce the risk of stroke or serious blood clots in patients with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality.[1] Pradaxa was approved by the U.S. Food and Drug Administration in October 2010. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
A new study released January 9 found that Pradaxa carries an increased risk of heart attack compared with other anti-coagulant medications.[2] The study found that patients taking Pradaxa have a 33% higher relative risk of heart attack or severe symptoms of heart disease than do patients taking other common treatments.[3]
The FDA is also investigating reports of serious bleeding events in patients taking Pradaxa.[4] Case reports on Pradaxa have noted increased bleeding associated with advanced age, renal impairment, and low body weight.[5] Bleeding can lead to serious injury or even fatal outcomes. Bleeding may be a complication of anticoagulant therapies. However, the FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected. [6]
Robins Kaplan Miller and Ciresi LLP is investigating Pradaxa. If you or someone you know has been injured or killed following use of Pradaxa and you wish to consult with a lawyer, please call us at 1-800-553-9910 or e-mail us by clicking on this link: contact us.
[1] http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
[2] Uchino and Hernandez, Dabigatran Association With Higher Risk of Acute Coronary Events, Archives of Internal Medicine, published online 1/9/2012.
[3] Id.
[4] http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
[5] Jacobs and Stessman, Dabigatran: Do We Have Sufficient Data?, Archives of Internal Medicine, published online 1/9/2012.
[6] http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
Copyright 2012. All rights reserved.
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