Bleeding and Pradaxa

Posted on Dec 8, 2011 in News | 0 comments

FDA Evaluating Reports of Serious Bleeding With Pradaxa

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The U.S. Food and Drug Administration (FDA) is evaluating postmarketing reports of serious bleeding events in patients taking Pradaxa^®. Pradaxa is an anticoagulant used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

At this time, the FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional, as abrupt cessation of anticoagulants can increase the risk of stroke. the FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

Quick Facts About Prada

• An anticoagulant known as a direct thrombin inhibitor.
• Approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with nonvalvular AF.
• Available as 75 mg and 150 mg oral capsules.
• From approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies.

Published December 8, 2011

 

Source: Pradaxa (dabigatran etexilate mesylate): Drug safety communication – safety review of post-market reports of serious bleeding events. U.S. Food and Drug Administration Website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/%20SafetyAlertsforHumanMedicalProducts/ucm282820.htm. Posted December 7, 2011. Accessed December 7, 2011.