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Pradaxa® (dabigatran etexilate mesylate) Capsules Gains Preferred Formulary Status with AARP®, Nation's Largest Provider of Medicare Part D Coverage
Date:5/19/2011

higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions.  These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer).  Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated

The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.  

For full PRADAXA prescribing information and medication guide, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

About the Storage and Handling of PRADAXA

PRADAXA must be stored in its original packaging(1) and patients should not transfer the capsules to pill boxes or pill organizers. (7) Once the bottle is opened, the product must be used within 30 days.(1) Patients must close the bottle tightly immediately after removing one capsule(1) and must not alter the child-proof cap.(7) It is recommended that patients date the bottle to expire 30 days after first opening. When more than one bottle is dispensed, patients should only open one bottle at a time.(7) When packaged in a blister package, each capsule should only be removed at time of use.(1)

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer I
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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