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.
Need a Pradaxa Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Pradaxa lawyers for a free lawsuit review.