The blood thinning drug Pradaxa, also known as dabigatran, is a relatively new anticoagulant medication that was announced as a substitute for warfarin. It’s frequently used to prevent the occurrence of strokes in patients who have atrial fibrillation.

Blood thinning drug Pradaxa, however, has been linked to bleeding complications and other serious adverse side effects since its arrival on the market.

Symptoms of Pradaxa bleeding may include headaches, lethargy, and dizziness; common nose bleeds and bleeding from gums; weakness in the body’s lower and upper extremity such as in the feet, lower legs, ankles, arms, and feet; coughing blood; brown or pink colored urine; black or red stool; and abnormal bleeding or bruising.

The blood thinning drug Pradaxa is also part of a class of drugs known as “direct thrombin inhibitors.” These drugs inhibit the function of a substance that causes blood to clot.

The blood thinning drug Pradaxa is also used to treat deep vein thrombosis and pulmonary embolism in patients. While deep vein thrombosis is a blood clot that formulates in the body’s legs, pulmonary embolism is a condition in which one or more arteries in the lungs becomes blocked by a blood clot.

The drug is also used to prevent DVT and PE in patients who have had a hip replacement surgery, and it can prevent blood clots that may become carried through the blood stream to the body’s upper extremities.

Reports of adverse events indicate that roughly 16.6% of patients who take Pradaxa may face a Pradaxa bleeding encounter. In addition, roughly 3.3% of those cases may involve serious bleeding, and 0.3% may suffer from brain hemorrhage from taking Pradaxa, respectively.

Within Pradaxa’s first three months on the market, there were roughly 307 adverse event reports filed with the U.S. Food and Drug Administration.

According to a 2010 QuarterWatch report, “within just weeks of its approval on October 2010, this new drug, approved to reduce the risk of stroke in patients with atrial fibrillation, moved to near the top of our adverse event rankings, with more reports than 98.7% of the drugs we regularly monitor.”

In 2011, the FDA also issued a drug safety communication informing the public and medical community that Pradaxa’s potential internal bleeding effects was being reviewed as a result of post-marketing reports of problems. The FDA stated that internal bleeding was a known adverse effect to all blood-thinners and anticoagulants. The agency said it would look into whether there is anything abnormal about Pradaxa’s internal bleeding side effects that may be more of a concern.

Compounding the risk of dangerous bleeding was the lack of an antidote. For the first five years that Pradaxa was on the market, there was no antidote available that could reverse its anticoagulant effect. While an antidote was eventually approved by the FDA, for several years Pradaxa patients had to live with the risk that any severe bleeding they may develop could be uncontrollable.