Pradaxa (generic, dabigatran) is a blood-thinning drug approved by the Food and Drug Administration (FDA) in 2010 as an alternative to warfarin for treating atrial fibrillation, which can lead to strokes.

Patients with atrial fibrillation are five times more likely to have a stroke than people who do not. However, Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, settled more than 4,000 Pradaxa bleeding lawsuits in May 2014 for $650 million.

No part of this settlement included admitting fault for Pradaxa’s side effects, or for any complications plaintiffs had experienced as a result of using their product.

Pradaxa rose in popularity very quickly once it was released. 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 any medication.

Sales for Pradaxa have only escalated. More than 3.7 million U.S. patients chose to use 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. Common side effects are indigestion, nausea, stomach pain, and heart burn. These side effects are more common in people over 75, people with kidney problems, or those with stomach or intestine bleeding.

For fewer people, Pradaxa can have serious side effects, which 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 death or brain hemorrhaging. Brain hemorrhages are extremely harmful.

Serious side effects after taking Pradaxa include bleeding, unusual bruising, coughing up blood, vomit that looks like coffee grounds, pink or brown urine, swelling or joint pain, headaches, dizziness, or weakness.

In 2011, the FDA received 817 reports of medical complications involving Pradaxa, and thousands more were reported elsewhere, totaling 3,781. Of these, over 500 were fatal.

In 2012, researchers found that out of 30,470 patients, those taking Pradaxa were more likely to have heart attacks than those taking warfarin. Another study found that Pradaxa causes a 33 percent increased risk of heart attack or severe symptoms of heart disease when compared to warfarin.

While Pradaxa and warfarin can both cause internal bleeding or brain hemorrhaging, excessive bleeding caused by warfarin can be counteracted. There are currently no available measures against excessive bleeding caused by Pradaxa.

Japan and Australia are both taking actions against Pradaxa, issuing safety warnings regarding bleeding risks. The Japanese Ministry of Health, Labour and Welfare (MHLW) recommended that physicians monitor patients for side effects of Pradaxa such as bleeding.

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.

The maker of Pradaxa, Boehringer Ingelheim Pharmaceuticals, has stated since this information was released that Pradaxa still offers more benefits than risks.

This information is part of the ongoing investigation into Pradaxa, which has spurred thousands of injured parties into filing Pradaxa lawsuits. These new studies reinforce the potential danger in taking Pradaxa, as well as the company’s reluctance to deal with this issue.

If you or someone you know has experienced any of the above symptoms, such as bleeding or brain hemorrhaging, due to Pradaxa, you may have cause for filing a Pradaxa bleeding lawsuit.