Dabigatran, you may know it at Pradaxa, the first in a string of potential blockbuster oral anticoagulants, has a few problems. Lack of effective reversal options, poor prescriber understanding of drug-drug and GFR interactions, and reduced dosing options should make physicians wary of this medication.
Well, it’s not.
This is a dataset gleaned by an ongoing physician audit covering ~4800 U.S. practioners between 2007 and 2011, used to estimate prescription trends for the U.S. Warfarin prescriptions were reasonably stable between 2007 and 2010, but then have dropped approximately 20% over the course of 2011. The medication taking up the slack? Dabigatran.
If you accept the findings from RE-LY, then you’re probably OK with its use in non-valvular atrial fibrillation. Unfortunately, 37% of the prescriptions were off-label, outside the FDA approved indications. Then, within the remaining 63%, there’s no breakdown for whether it was valvular or non-valvular atrial fibrillation. So, the percentage of off-label use is probably even higher than found in the data.
It would seem to be prudent to be cautious with a new medication that’s already being investigated by the FDA for serious bleeding complications. Luckily for the manufacturer, that’s not happening, and prescription expenditures for dabigatran already exceed those for warfarin – over $160 million per quarter.
“National Trends in Oral Anticoagulant Use in the United States, 2007 to 2011”
http://www.ncbi.nlm.nih.gov/pubmed/22949490