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Posts Tagged ‘Pradaxa not indicated for mechanical valves’

Heading out-of-town for a conference for a few days – but in the meantime, I’ll be working one several case reports from recent surgeries.

We will also be talking about the latest stories from the Heart.org about the recent rise in off-label use of dabigatran (Pradaxa) use.

Rise in Pradaxa (dabigatran) linked to off-label use

Off-label uses

While this new anti-coagulant has been touted as the ‘easy’ alternative to warfarin since serum monitoring is not required – it is currently approved for the use of non-valvular atrial fibrillation only in the United States.

While it is approved for deep vein thrombosis prevention (DVT prophylaxis) in Europe – it is not, and should not be used for anti-coagulation in patients with mechanical valves.  

Off-label use in Canada leads to life-threatening complications

However, that is apparently exactly how doctors in Canada have been using it – with life-threatening consequences.  In a separate article at the Heart.org, doctors report that two female patients with mechanical valves who were recently switched from warfarin to dabigitran suffered from valvular thrombosis.

The “easy button” strikes again

More concerning, these patients had previously been successfully managed on warfarin without problems prior to the switch.  (So they were taken off a drug that was working well – and switched to a drug that is not approved for this condition because it was perceived to be easier to use.)

Within one month of the switch both patients began experiencing symptoms and were then diagnosed with valvular thrombosis.  Fortunately, neither of these patients died – but they certainly could have.

My former boss had a saying, “the enemy of good is better” meaning that if we try too hard to improve on something that is already working  – we unnecessary risk the lives and health of our patients.

Anticoagulants are not all the same

This just brings home the message that drugs that may seem similar, aren’t.  The way that dabigatran works is very different that warfarin, aspirin, clopidogrel (Plavix), abciximab (Reopro) or the other myriad of anti-coagulation type drugs.  Some of these drugs work on platelets – some of these drugs work on different parts of a complex mechanisms of coagulation (the coagulation cascade).   ‘Anti-coagulants’ is just a blanket term for these medications – and certainly doesn’t fully cover the intricacies of the pharmacology involved.  ‘Easy’ it isn’t – but medicine rarely is.

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