Pradaxa Approved for DVT/PE Despite Safety Concerns

April 7, 2014 — Despite safety concerns and thousands of lawsuits, the oral blood-thinning medication Pradaxa (dabigatran) has been approved to treat certain patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).

DVT and PE (also known as a venous thromboembolism or VTE) occurs when blood clots in the legs travel in the bloodstream and get trapped in the lungs. The condition affects an estimated 900,000 people every year, and approximately one-third of cases are fatal.

Pradaxa is approved for DVT and PE in patients who have been treated with a parenteral blood-thinner for 5-10 days. It can also be used to reduce the risk of recurrent DVT or PE.

Pradaxa was originally approved in 2010 for the prevention of stroke in patients with atrial fibrillation, which is a type of irregular heart rhythm that can cause blood clots.

The approval of Pradaxa for DVT and PE was based on several clinical trials. The RE-COVER and RE-COVER II trials found that patients on Pradaxa fared better than patients on warfarin when treated for a median of 174 days. Pradaxa was associated with lower rates of overall bleeding but higher rates of gastrointestinal bleeding (3.1% vs. 2.4%) compared to warfarin.

As Boehringer Ingelhei pushes to expand approval of Pradaxa, many experts warn that it can have serious side effects. Unlike warfarin, which can be de-activated with a dose of Vitamin K, Pradaxa has no quick reversal agent. In an emergency, doctors may have problems reversing the blood-thinning effects of Pradaxa to stop bleeding.

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