The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(10) Safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.(10)
In the RE-LY trial, all clinical outcomes were adjudicated in a blinded manner to assess outcomes for each treatment.(10)
About Pradaxa® (dabigatran etexilate) Capsules
Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
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. Consider evaluation of renal function. Discontinue PRADAXA in patients with active pathological bleeding.
Temporary Discontinuation of PRADAXA
|SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.|
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