Pradaxa is an anticoagulant drug that was manufactured to compete with warfarin. However, alleged bleeding side effects of Pradaxa have concerned the medical community.

Pradaxa, generically known as dabigatran, is a Direct Thrombin Inhibitor and was approved by the U.S. Food and Drug Administration in 2010. Pradaxa was brought onto the market to be superior to warfarin because it was initially thought to require less patient monitoring than warfarin.

Pradaxa was approved to help prevent strokes. By 2012, just two years after its approval, nearly 4 million Americans had a prescription for Pradaxa. In the first quarter of that year, sales across the world reached $209 million.

But the bleeding side effects of Pradaxa can be serious. In the first two years that Pradaxa was on the market, over 500 deaths were reported to be associated with its use.

A large multidistrict litigation (MDL) was settled in May 2014 for thousands of product liability and personal injury lawsuits citing bleeding side effects of Pradaxa as a cause for death and injury. Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, agreed to pay $650 million to settle these lawsuits.

Pradaxa is often used with patients who suffer from atrial fibrillation. It is also used to treat patients by preventing venous thromboembolism and pulmonary embolism.

Up until just recently, the bleeding side effects of Pradaxa had no antidote. Essentially, if a Pradaxa patient began to suffer a hemorrhage, there was no way to stop the bleeding.

Other bleeding side effects of Pradaxa include gastrointestinal bleeding and other uncontrollable internal bleeding. Patients should seek a doctor’s help if they experience coughing up of blood, pink or brown urine, headaches, dizziness or weakness, unusual bruising, vomit that looks like coffee grounds and swelling or joint pain.

This lack of antidote, critics claimed, has led to uncontrollable bleeding side effects of Pradaxa patients and at times, their deaths.

Just recently, Praxbind, Pradaxa’s antidote, was released by Boehringer Ingelheim. However, this new drug has come too late for many patients. In fact, Pradaxa was one of the most frequently mentioned drugs in the database of adverse event reports compiled by the FDA in 2011. In that same year, 500 adverse reports regarding bleeding side effects of Pradaxa were reported. Each one of these reports described disabling or deadly bleeding.

If you believe that you have suffered from bleeding side effects of Pradaxa, you may be entitled to legal compensation.