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RE-ALIGN Trial Halted: Pradaxa Mechanical Heart Valve Warning Issued

The FDA issued a press release today warning doctors not to prescribe the controversial anticoagulant Pradaxa to individuals with mechanical heart valves.

December 20, 2012 – The U.S. Food & Drug Administration (FDA) issued a press release today warning doctors not to prescribe the controversial anticoagulant Pradaxa (generic: dabigatran) to individuals with mechanical heart valves. 

Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

According to the FDA’s press release, drugmaker Boehringer Ingelheim halted the phase II RE-ALIGN trial, which tested three doses of Pradaxa in patients with mechanical valves, after investigators noted an abnormally large number of adverse events associated with the drug compared to warfarin (a staple anticoagulant medication that has been in use for more than 50 years in the United States). These complications included heart attacks, strokes, thrombus formation, and post-operative internal bleeding.

First approved by the U.S. Food & Drug Administration (FDA) in October 2010, Pradaxa is prescribed for the prevention of stroke in patients suffering from nonvalvular atrial fibrillation (irregular heartbeat). Shortly after hitting the market, bleeding concerns arose internationally after at least 50 deaths were linked to the drug. The FDA subsequently investigated the matter and determined that there was no excess risk of bleeding with Pradaxa.

Although serious side effects have been associated with Pradaxa use in patients with mechanical heart valves, the medication has not been tested on individuals with bioprosthetic valves (those made from natural body tissues). People with these types of valves do not typically require anticoagulant drugs, and the FDA has not made any recommendation for or against their use. The administration simply urged doctors to evaluate patients with all types of prosthetic heart valves for the most appropriate medical therapy.

Do I Have a Pradaxa Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

Free Confidential Case Evaluation

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