A Look At The Events And The Evidence Leading Up To This Latest FDA Action Concerning The Safety Of Pradaxa
We set the stage with this December 19, 2012 drug company press release, "Boehringer Ingelheim Pharmaceuticals, Inc. Announces Updated Safety Information for Pradaxa® (dabigatran etexilate mesylate) Related to Prosthetic Heart Valves":
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa® (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
The decision to add the contraindication was made following an interim analysis of results from the Phase II RE-ALIGNTM study in patients with mechanical prosthetic heart valve replacement, a patient population different than the currently labeled indication for PRADAXA. The RE-ALIGNTM study did not enroll any U.S. patients. The interim analysis showed an increased incidence of thromboembolic and bleeding events in this specific patient population treated with dabigatran etexilate compared to warfarin.
In summary, the events leading up to this December 2012 Pradaxa label change are set forth in this December 20 Medscape news report, "FDA Contraindicates Dabigatran for Those With Mechanical Heart Valves":
The US FDA is following in the footsteps of the European Medicines Agency (EMA) in warning that the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) should not be used to prevent stroke or major thromboembolic events in patients with mechanical (also known as mechanical prosthetic) heart valves.
And the agency reveals the reason behind the recent decision to stop the RE-ALIGN trial with [Pradaxa (dabigatran)] in such patients: dabigatran users were more likely to experience strokes, MI, and thromboses forming on the mechanical heart valves than were users of warfarin, details that have hitherto not been reported by Boehringer Ingelheim. There was also more bleeding after valve surgery in the dabigatran users than in the warfarin users, says the FDA, which is now stating that dabigatran is contraindicated in patients with mechanical heart valves.
Here is the FDA announcement and evidence regarding the Pradaxa - mechanical heart valve safety issue: "FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves".
And here is the so-called "Dear Doctor" letter about Pradaxa being used by mechanical heart patients that was sent out in Canada: "Pradaxa/Pradax (dabigatran etexilate) - New Contraindication in Patients with Prosthetic Heart Valves Requiring Anticoagulant Treatment Due to their Valvular Status - For Health Professionals".
Going back to the December 20 Medscape article:
In the US, [Pradaxa (dabigatran)], a direct thrombin inhibitor, is indicated to prevent strokes and thromboembolic events in patients with nonvalvular atrial fibrillation (AF), but the FDA is stressing that this does not include patients with AF caused by heart-valve problems. [Pradaxa (abigatran)] is also approved for nonvalvular AF in Europe, and it is indicated there for venous-thromboembolism (VTE) prophylaxis after hip- and knee-replacement surgery.
And lastly, as an aside, we let you know about this December 21, 2012 Pharmalot post by Ed Silverman: "The Clot Thickens: Australia May Remove Pradaxa".
We will continue to watch for further developments concerning Pradaxa here in the U.S. and elsewhere.
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