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New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion
Date:1/5/2011

ses a substantial economic burden to the healthcare system,(9) specifically the high costs associated with stroke.(10)  

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

- Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke.  Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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Related medicine technology :

1. New PLATO Sub-Analysis of CABG Patients Presented at ACC
2. Boehringer Ingelheim Announces Enrollment is Complete for the Largest Atrial Fibrillation Outcomes Trial - The RE-LY(TM) Study
3. Data Published in The Lancet Compare Dabigatran Etexilate to Dose-Adjusted Warfarin Across RE-LY® Trial Centers
4. New Analyses of Data From RE-LY Trial, Involving Oral Anticoagulant Pradaxa, to be Presented at American Heart Associations Scientific Sessions
5. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
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8. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
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