Pradaxa, or dabigatran, is an anticoagulant that helps reduce the ability of the blood to clot.

In people who have atrial fibrillation, a rapid or irregular heart rate that causes poor blood circulation, Pradaxa can reduce the risk of blood clots from forming. The medication can also be prescribed to inhibit the formation of blood clots in veins of the lower extremity, termed DVT, or deep vein thrombosis and for pulmonary embolism, or blood clots that form in the lungs.

Typically, anticoagulant medications prevent strokes and blood clots from forming by decreasing the amount of vitamin K levels that are in the bloodstream. Pradaxa, however, doesn’t decrease the amount of vitamin K, but instead inhibits the enzyme thrombin. This enzyme prevents platelets from conjoining and forming clots.

Recent studies have shown, however, that pervasive Pradaxa bleeding risks and other dangerous side effects can cause trouble for patients taking the anticoagulant medication.

Reports indicate that Pradaxa bleeding risks have led to more than 500 patient deaths since the drug entered the market. In response to the widespread reports of bleeding incidents occurring, an antidote to Pradaxa uncontrolled bleeding, Praxbind, was formulated and quickly approved by the FDA in 2015.  But that was far too late for many patients.

Pradaxa bleeding risks can occur from simply taking the medication. Warnings indicate that the prescription should not be taken if a patient possesses an artificial heart valve, or if any active bleeding has resulted from injury, surgery, or any other cause.

Since Pradaxa keeps the blood from coagulating or inhibits blood clots from forming, the prescription can make it easier for patients to bleed, even if from a minor injury resulting from a bump on the head or a fall.

Pradaxa bleeding risks can occur as a particularly serious blood clot around the spinal cord, if a patient has undergone a spinal tap, has received a spinal anesthesia and has had a genetic spinal defect or spinal catheter.

Pradaxa bleeding risks may also occur if a patient has had a stomach ulcer, had recurring bleeding in the intestines or stomach, has had kidney disease, or taken other medications that can elevate bleeding risks such as aspirin, or heparin, or an NSAID (nonsteroidal anti-inflammatory drug) regularly. The risks increase if the patient is older than 75.

Symptoms of Pradaxa bleeding risks may involve unexplained bruises, painful joints, bloody urine, red/purple dots underneath the skin, coughing fits that produce blood or vomit, and abnormal bleeding from the nose or rectum.

History of Pradaxa

Pradaxa, approved by the FDA in 2010, quickly became a popular prescribed drug with revenue mounting $1.2 billion in 2014.

It was first manufactured within the class of drugs known as NOACs, or novel oral anticoagulants. Other drugs a part of this class include, Eliquis, manufactured by Pfizer and Bristol Myers- Squibb, and Xarelto, manufactured by Bayer.

These NOAC drugs were marketed as safer and easier to use than their predecessor, warfarin (Coumadin). Some patients now claim, however, that the bleeding risks outweigh the ease of use benefits.

If you or someone you love suffered a bleeding injury from Pradaxa or another anticoagulant, you may be able to file a claim against the manufacturer. A Pradaxa lawyer can answer any questions you may have and help you decide if a Pradaxa lawsuit is the right path for you.