Saturday, June 09, 2012

Bleeding and Pradaxa (and other novel anticoagulants)

Bleeding on blood thinners is a common problem. Until recently the drill was straightforward. Not so much anymore. Enter the novel anticoagulants, which require novel treatment strategies.

This ToxTalk podcast (the second half of it) contains a nice discussion of the ins and outs of dabigatran (Pradaxa) associated bleeding. When a patient on dabigatran is bleeding the first decision is whether or not it will suffice to merely temporize by stopping the drug, waiting for its effect to wear off and supporting the patient in the meantime with volume resuscitation and packed red cells. If not (life threatening bleeding such as into the head) you're in a bit of a pickle. Then the issue becomes reversal but nobody seems to really know how to go about it! For all the talk about reversal agents none have been proven to work. As the tox experts pointed out we shouldn't expect any of them to work because they all have their effects upstream from dabigatran's site of action.

The discussants cited this paper which showed that 4 factor PCC had no effect toward reversing any of the coagulation tests altered by dabigatrin (although it did reverse rivaroxaban effects).

While there are no outcome based data hemodialysis accelerates removal of the drug and is, according to the discussants, a “reasonable” option for treatment in life threatening situations.

Since there is so much dispute and uncertainty about how to handle dabigatran associated bleeding (do your heme people know what to do? Are the nephrologists on board?) it is important for institutions to have protocols set up in advance. That was perhaps the most important point made by the tox experts.

1 comment:

Martha Schaefer said...

If this is the case, why the manufacturer wouldn’t put a warning to its product label as a warning protocol? At least, the patient can be aware of the side-effects and therefore avoid excessive bleeding by avoiding possible injuries. Excessive bleeding can be as dangerous as the stroke so the risk/danger is still the same whether a patient take this drug or not. Also, I observed especially online that cases of a Pradaxa lawsuit keep rising which indicates that the drug is really a mess. Better take Warfarin, though it needs frequent blood monitoring but at least the effects can be reversed.