There was good news recently in the atrial fibrillation world.
Though no surprise to heart rhythm doctors, an FDA investigation reveals no evidence that new cases of bleeding are any higher with dabigatran (Pradaxa) than with warfarin.
The full statement from the FDA is here.
The assessment was undertaken because after approval of the novel anticoagulant (blood-thinner) a large number of adverse events were reported to the FDA. Despite conscientious medical opinions, these ‘bad drug’ reports led to a public perception that dabigatran was more dangerous than really dangerous drugs.
Smart folks who looked at these events came to four conclusions:
- Most of the adverse events related to bleeding, which is not surprising with a drug that blocks clotting.
- Early enthusiasm for the first warfarin replacement drug in decades led to inappropriate use of dabigatran, such as in frail elderly patients or those with chronic kidney disease.
- It was impossible to judge the rate of bleeding events because no one knew how many had been started on the drug. All that was reported was the numerator.
- Adverse outcomes that occur in patients on new drugs get reported more vigorously than events on old drugs. No one would think of reporting a bleeding event with warfarin. These are expected and common. It’s an anticoagulant after all.
The reason why I find this FDA report to be good news is not that it confirms the safety of dabigatran. No drug is completely safe. What gives me hope is that this news might allow us to re-emphasize the most important aspect of AF care: shared decision making.
Of course anticoagulants increase the risk of bleeding events. That’s how they work. The reason why heart-rhythm doctors recommend a drug that increases the risk of bleeding is that it’s the only proven way to reduce the risk of stroke. The higher the risk of stroke, the greater the benefit of the drug. It’s a shared-decision between patient and doctor. A doctor’s job is to guide a patient through this delicate and nuanced decision. It’s about balancing risk: the risk of stroke versus the risk of bleeding.
The thing about stroke: It’s worse than bleeding. There are fewer mulligans with obstructed blood vessels in the brain. Stroke kills and disables permanently. Bleeding isn’t good either, but far more often than in stroke, patients with bleeds survive unscathed–that is, without a permanent drool or paralysis or life in a nursing home.
You know I don’t like the word need. I don’t tell patients they need to take an anticoagulant. I do my best to tell them of the risks of being on the drug versus being off. Then I try not to be attached to their decision.
John Mandrola is a cardiologist who blogs at Dr John M.