Pradaxa For Mechanical Heart Valves?

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Eddie GVKITT Says:

My wife has a leaflet valve in the mitral position, an A-V node ablation with pacemaker and constant A-fib. She has been on coumadin for 30 years and within the past few years has begun to get purple patches on her arms that are not bruises. They appear to be very near to necrosis as any damage to these areas becomes an open lesion. She also has unstable INR and tests weekly with a CoaguChek meter. Her cardiologist is unwilling to try the 100mcg concurrent vitamin-K therapy as an attempt to stabilize INR.

It would appear that Pradaxa if approved for mechanical valve protection would get her out of the high risk of INR instability, the purple spots on her arms and maybe prove cost effective. My question, is there any hope that Pradaxa will be approved for her condition in the near future? Her quality of life situation is depressing and since she is a senior she quite frankly just doesn’t get much attention.

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FYI Says:

Pradaxa has not been studied in patients with mech. Valves, it would be off label In those patients. However docs use drugs off label In certain situations, check with her doc and see what they say.

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Verwon Says:

FYI is correct, a doctor can prescribe any drug off-label, they don't have to strictly go by the FDA approvals.

It hasn't been studied in cases such as your wifes, so there is no way of knowing how it will work for her or any possible safety risks, but it has been proven to be as effective as the Warfarin in Coumadin and to give much more stability to the INR levels.

You can learn more about it here:


How is she doing?

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gary stewart Says:

Seems like an obvious clinical trial, with plenty of willing participants... I'll be first in line.

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Gordon Fleming Says:

I have a St Jude's aortic valve and have been on Warfarin, Coumadin, for over 10 yrs. I had a monor stroke (2006) and have just had nuero surgery to release pressure (fluid) on my brain following a bump on my head.
I am excited about new drugs like Pradaxa. When will these drugs be approved for patients like me? I see a cardiologist once a year and due again in Aug 2011.
Await your reply.
Gordon Fleming.

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DennyB Says:

Hasn't Pradaxa been prescribed for pts with mech. valves in Europe?

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deedee Says:

I would not recommend Pradaxa for a patient with a heart valve. Reason saying, my brother-in-law was on coumidin for many years, also has a heart valve, was switched to Pradaxa, and within two weeks has had a stroke, has lost his vision. The sad thing about it is if you have a heart valve then you cannot take the medicine used for reversing the stroke....but with coumidin he would have been able to have used it...

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