FDA posting on Pradaxa 12/20/12

ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.

2 Comments

Soorry if this taken as a

by janetinak - 2012-12-22 06:12:14

"scare notes". I was simply relaying info from the FDA put out THIS WEEK based on a large study. Take it for its worth-an FYI.

Janet

Be careful with scare notes.

by PJinSC - 2012-12-22 12:12:29

This is not new news. The disclaimer about heart valve problems has been part of the Pradaxa labeling since it first came out. I have A-fib (not heart valve related) and had to go to Pradaxa two years ago because after ten years I was getting so I could not tolerate warfarin and could not get theraputic in spite of very high doses and getting stuck every week or two was getting to be a real you-know-what. I do not bleed as badly now and feel better. No more headaches or weird out-of-body feelings, which were indicators that I was getting too thin (INR passing 3.5 or higher). Warfarin has many undesirable side effects. Look it up.

You know you're wired when...

You have rhythm.

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