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New Warnings About Pradaxa

by Dr. Sharon Orrange on November 20, 2012 at 2:06 pm

The buzz around Pradaxa has deflated a bit with reports of bleeding risks. Pradaxa (dabigatran) changes the body’s clotting system and thins the blood to prevent clots from forming. Pradaxa is exciting because it is a good alternative to warfarin in patients with atrial fibrillation. Warfarin (Coumadin), unlike Pradaxa, requires serial blood tests to check INR. Pradaxa is much more convenient than warfarin, but is it riskier?

Pradaxa works. In large studies, Pradaxa 150 mg twice daily was more effective for stroke prevention than warfarin in patients with atrial fibrillation. Based on this, in the fall of 2010, the US Food and Drug Administration (FDA) approved the use of dabigatran for patients with atrial fibrillation who are at risk for stroke.

Other than the cost of Pradaxa all news was quite good. That has changed as now there are concerns being raised about Pradaxa. Here are the details: Healthcare professionals and patients were notified of reports of serious bleeding associated with use in patients at a high risk of bleeding, elderly patients, or patients with kidney impairment.

Here are the new recommendations for Pradaxa (dabigatran):

• Due to the risk for bleeding when used in patients with kidney disease, kidney function needs to be assessed before and during Pradaxa treatment.

• If therapy is used in elderly patients (> 75 years of age) or in any patient with kidney impairment, kidney function needs to be checked at a minimum of once per year.

• The FDA is still investigating new reports of serious bleeding associated with dabigatran use.

• When Pradaxa was approved, rates of serious bleeding were similar compared to warfarin but recent reports suggest serious bleeding rates are higher than expected.

The FDA will provide updates as they are available. Stay tuned.

Dr. O.

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