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Despite Fatalities, Pradaxa Manufacturer Seeks Expanded Approval

Pradaxa is currently approved by the Food and Drug Administration (FDA) for stroke-prevention in patients with atrial fibrillation. Despite reports of over 200 fatalities from the blood thinner with no off switch, Pradaxa manufacturer Boehringer Ingelheim is undertaking a study aimed at expanding the approved use of Pradaxa to those who have received mechanical heart valves.

The study, Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGigatran etexilate in patients after heart valve replacemeNt, short-named RE-ALIGN, is aimed at finding appropriate dosing of Pradaxa in heart valve patients as an alternative to warfarin. Worldwide, 30,000 people receive a mechanical heart valve annually. Each mechanical heart valve recipient will typically have to take anti-coagulant medication for the rest of his or her life.

According to Professor Frans Van de Werf, Department of Cardiovascular Medicine, University Hospitals Leuven, Belgium, "Pradaxa® has already been proven to be a safe and efficacious anticoagulant treatment for stroke prevention in patients with atrial fibrillation." Expanding the approved use of Pradaxa to heart-valve replacement patients would give these patients a long term alternative to warfarin.

Investigators running the study cite warfarin's shortcomings as a reason for introducing Pradaxa to heart-valve patients, but do not discuss Pradaxa's own shortcomings, notably, fatal internal bleeding that cannot be easily controlled. Patients taking warfarin often have less of the anti-clotting drug in their system than is desired, even with consistent monitoring, according to investigators.

Pradaxa is not yet approved for heart-valve patients other than those involved in the RE-ALIGN study.

Source: Business Wire, "First study to evaluate alternative to warfarin for mechanical heart valve patients launched with Pradaxa® (dabigatran etexilate)," June 20, 2012


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