Blood-Thinner Pradaxa: What You Should Know

Blood-Thinner Pradaxa: What You Should Know.

Concerns about Pradaxa surfaced 2 years ago, he says, when doctors began reporting a larger number of serious and sometimes fatal bleeding problems in older patients on the drug.

The claim by the company that the drug needs no blood-level monitoring is misguided, Moore says. “It turns out the company has had data for several years, showing the amount of anticoagulation [blood thinning] varied [from patient to patient] more than five-fold.”

That means, Moore says, that “the same dose could produce widely varying effects on blood clotting. Some patients would be at extremely high risk of bleeding. Others would not get a strong enough blood clotting effect to serve its purpose, reduce the risk of stroke.”

Do the phrases “serious and sometimes fatal bleeding problems”  combined with the drug maker’s withholding of data bother anyone?  And yet another example of putting profits before people.

Update 07.27.14

I found another fine article on the Pradaxa mess.  Follow the link to The Poison Review. There you will find more details on this story and more links for further reading, including a link to the full text BMJ article.

The Institute for Safe Medication Practices reported that in 2011 there were 3781 serious adverse effects and 542 patient deaths reported in the United States in association with dabigatran. In comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period. – See more at: http://www.thepoisonreview.com/2014/07/27/must-read-marketing-vs-medicine-in-the-case-of-pradaxa-dabigatran/#sthash.tpAapuE6.dpuf

Must-read: marketing vs. medicine in the case of Pradaxa dabigatran | The Poison Review.

Update 08.22.14

Getting the dabigatran Pradaxa story right… Correcting four common mistakes..

If you’re not totally confused by now you should be.

AHA: No Excess Bleeding Risk with Dabigatran (Pradaxa)

Although the FDA review discounted an excess bleeding risk with dabigatran, it did not address another potential concern — the ability to reverse the anticoagulant effect acutely in cases of emergency.

Antman acknowledged that there is no specific, approved antidote for dabigatran or any of the novel anticoagulants, although it is an area of active investigation and the topic of several studies that will be presented at the AHA meeting in the coming days.

He said it’s not true, however, that clinicians don’t have any options. Intravenous administration of blood coagulation factors — prothrombin complex concentrates that are available in every hospital — can help to reverse the effect, though not completely.

In comparison, the effects of warfarin can be reversed with the administration of vitamin K. Antman noted. But that that doesn’t always work either, and patients can die because of it, he added.

via AHA: No Excess Bleeding Risk with Dabigatran.