FDA approved Pradaxa yesterday, but attached a hated REMS program to it. This basically means more paperwork is attached to the drug for docs.

I personally dislike these REMS programs, but the manufacturers probably really hate them because they reduce uptake of a new drug.  If you have a disincentive to use a drug, you will try to use something else.

We don't get new blood thinners all that often.  Dabigatran, the generic name for Pradaxa, is what they call a direct thrombin inhibitor, so it has a unique mechanism of action.

The label says it's approved for atrial fibrillation, but I think it will be an uphill climb to unseat coumadin in this indication.  The dosing is twice a day (!), as if older folks with atrial fib aren't already taking enough pills!

Here's the 2009 NEJM article answering the question, "How does Pradaxa stack up against coumadin?"

The answer is: in a low dose, it's the same with less bleeding.  In a high dose, it's better, but more bleeding.

It's like the "ours goes to 11" joke.  Why not just make 10 louder? 

Why not just increase the coumadin dose to target an INR of 2.5 to 3.5 and get similar bleeding rates and probably greater efficacy in stroke prevention in atrial fib?  Has this study been done?

Are cardiologists going to participate in the REMS program?  Seems like they have a lot on their plate already. 

Better efficacy but more bleeding, and a REMS program.  We'll see.

Probably the better indication will be prophylaxis for orthopaedic surgery, perhaps we'll see this in a few months.