Pradaxa (dabigatran) is a blood-thinning drug approved by the FDA in 2010. Pradaxa was created to improve upon warfarin, the old staple for treating atrial fibrillation, a condition which can lead to strokes.

However, Pradaxa’s manufacturer (Boehringer Ingelheim Pharmaceuticals) has been facing thousands of dangerous drug lawsuits in the past year which allege serious Pradaxa bleeding side effects that the company failed to warn about.

Once it was released into the market, Pradaxa rose in popularity very quickly. 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 the anticoagulant have only escalated. More than 3.7 million U.S. patients were prescribed Pradaxa by mid-2012.

The number of patients choosing Pradaxa has risen, despite costing $3,000 yearly instead of only $200, the cost of generic warfarin. Many patients opt to use Pradaxa because, unlike warfarin, it does not require frequent blood testing. In clinical trials, Pradaxa did outperform warfarin, more effectively reducing risk of stroke.

Pradaxa, like other anticoagulants, may cause bruising or bleeding from even minor cuts. For most Pradaxa users, side effects are very minimal. For others, this is apparently not the case.

For fewer people, Pradaxa can have serious side effects, which include heart attacks, liver failure, uncontrolled bleeding, and even death. Pradaxa bleeding side effects are the most common of these more serious side effects, and can cause brain hemorrhaging or death.

Pradaxa bleeding side effects are extremely dangerous, because the body’s normal way of stopping internal bleeding is by forming a clot. 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 internal bleeding or brain hemorrhaging, excess bleeding caused by warfarin can be counteracted. There are currently no available measures against excess Pradaxa bleeding side effects

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

According to a study by the University of Pittsburgh, 9% of Pradaxa users experienced major bleeding complications, compared with 6% of warfarin users. Pradaxa users also tended to experience these complications in the stomach and intestines, while warfarin users experienced more bleeding in the head. The survey found that African-American patients, as well as patients with chronic kidney disease, were more likely to experience major bleeding complications after using the new generation blood thinner.

Pradaxa’s manufacturer does not require the drug to be monitored during use, and insists that it these kinds of measures are still not necessary. Boehringer Ingelheim Pharmaceuticals has stated since this information was released that Pradaxa still offers more benefits than risks.

If you or someone you know has experienced Pradaxa bleeding complications, you may have cause for filing a dangerous drug lawsuit against the manufacturer.