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Despite Safety Concerns, Pradaxa Approved for DVT/PE

Despite Safety Concerns, Pradaxa Approved for DVT/PE

April 7, 2014 — Despite concern about the bleeding risks of Pradaxa (dabigatran), Boehringer Ingelheim has received approval for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral blood-thinner for 5-10 days.

These life-threatening events occur when blood clots grow deep inside the body, usually the lower legs, and travel through the bloodstream until they get trapped in the lungs. Every year, about 900,000 Americans have a combined DVT/PE (also known as venous thromboembolism or VTE), and about one-third of cases are fatal.

The approval was based on data from several clinical trials demonstrating Pradaxa’s superiority to warfarin. The RE-COVER and RE-COVER II trials showed that Pradaxa was associated with lower rates of bleeding overall, but higher rates of gastrointestinal bleeding (3.1% vs. 2.4%). This finding was corroborated in the RE-MEDY trial.

The RE-SONATE trial found that Pradaxa reduced the risk of DVT and PE recurrence by 92% compared to a placebo. However, it was associated with higher rates of bleeding (10.5% vs. 6.1%), non-major bleeding, and gastrointestinal bleeding.

Boehringer Ingelheim is currently facing thousands of lawsuits from people who had severe bleeding on Pradaxa. Although bleeding is a well-known risk of all blood-thinners, Pradaxa belongs to a new generation of blood-thinning drugs that currently have no antidote. In an emergency, the blood-thinning effects of warfarin can be reversed with a dose of Vitamin K. The only way to de-activate Pradaxa is with several hours of dialysis.

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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