The makers of the blood-thinning drug Pradaxa have been facing thousands of lawsuits in the past year, alleging that the company failed to adequately warn about serious Pradaxa bleeding complications.

Manufactured by Boehringer Ingelheim Pharmaceuticals, Pradaxa (dabigatran) was approved by the FDA in 2010. Pradaxa was created to improve upon warfarin, the old staple for treating atrial fibrillation.

Strokes are a primary concern for patients with atrial fibrillation, as the condition makes them five times more likely to have a stroke than people who do not have the condition.

Once it was released into the market, sales for Pradaxa began to grow rapidly. After only one year on the market, 16 percent of patients with atrial fibrillation had chosen to switch to Pradaxa, while 44 percent were taking warfarin. (The other 40 percent did not take medication.)

Sales for Pradaxa have continued to escalate since its release, and the numbers are expected to keep climbing. More than 3.7 million U.S. patients had chosen to use Pradaxa by mid-2012. One of Pradaxa’s main selling points is that it, unlike generic warfarin, does not require frequent blood testing or monitoring.

Pradaxa Bleeding Complications

Pradaxa, like similar anticoagulants, may cause bruising or bleeding from even minor cuts. For most Pradaxa users, side effects are very minimal. For others though, lawsuits allege that this substitute for warfarin can cause major Pradaxa bleeding complications.

Pradaxa’s serious side effects allegedly include heart attacks, liver failure, uncontrolled bleeding, and even death. Excessive bleeding is the most common of these more serious side effects, and can cause brain hemorrhaging or death.

Pradaxa bleeding complications are extremely dangerous for patients, because the body’s normal way of stopping internal bleeding is by forming a clot.

However, while a patient is on blood thinners, those clots cannot form – even to fix such issues as minor bumps and bruises. When the issue at hand is major internal bleeding, the problem becomes much worse, especially for Pradaxa users.

While Pradaxa and warfarin can both cause and escalate internal bleeding or brain hemorrhaging, excess bleeding caused by warfarin can be counteracted. There are currently no available measures, such as an antidote, to stem excess bleeding caused by Pradaxa.

In 2011, the U.S. Food and Drug Administration received 817 reports of Pradaxa bleeding complications, and thousands more were reported elsewhere, totaling 3,781. Of these, over 500 were fatal.

This number of fatalities has been cause for concern in Pradaxa users, and has contributed to many patients’ willingness to file Pradaxa lawsuits.

According to these lawsuits, recent studies back up the rising number of Pradaxa bleeding complication reports. A study by the University of Pittsburgh found that 9 percent of Pradaxa users experienced major bleeding complications, while only 6 percent of warfarin users experienced such complications.

Though there is only a 3 percent difference, warfarin users who suffered from major bleeding complications had access to a way to stop the bleeding. Pradaxa users who experienced major bleeding complications had no antidote.

Filing a Pradaxa Bleeding Complications Lawsuit

Many patients who have suffered from Pradaxa bleeding complications have chosen to file lawsuits as a result. If you have experienced any of the above symptoms such as bleeding or brain hemorrhaging due to Pradaxa, you may have cause for filing a Pradaxa bleeding complication lawsuit.