Study of Pradaxa in Mechanical Heart-Valve Patients Halted

September 9, 2013 — Patients with mechanical heart-valves should not be treated with Pradaxa (dabigatran) instead of warfarin, according to a study published in the New England Journal of Medicine this month. The study raises serious concerns about the link between Pradaxa and heart attacks.

The RE-ALIGN clinical trial was terminated prematurely because patients on Pradaxa suffered more thromboembolic and bleeding events than patients on warfarin.

Of the 252 patients in the study, 168 were given Pradaxa and 84 were given warfarin.

  • Thromboembolic events (stroke, transient ischemic attack, systemic embolism, heart attack, or death) occurred in 15 patients on Pradaxa (9%) and 4 patients on warfarin (5%).
  • Nine patients (5%) on Pradaxa had a stroke, and no patients on warfarin had a stroke.
  • Major bleeding occurred in 7 patients on Pradaxa (4%) and 2 patients (2%) on warfarin.
  • All patients who developed bleeding also had pericardial bleeding (accumulation of blood around the heart).

The researchers concluded:

“Dabigatran is not appropriate as an alternative to warfarin for the prevention of thromboembolic complications in patients who require anticoagulation after the implantation of a prosthetic heart valve.”

What is the problem with Pradaxa?

Pradaxa (dabigatran) is a member of a new class of blood-thinners called direct-thrombin inhibitors. Introduced in 2010, Pradaxa was the first new blood-thinner approved since warfarin was approved in the 1950s. Unlike warfarin, which can be inactivated with a dose of Vitamin K, Pradaxa has no quick reversal mechanism.

Drug-maker Boehringer Ingelheim is acing a growing number of lawsuits alleging that the company has inadequately warned about the bleeding risks and lack of a reversal mechanism associated with Pradaxa.

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