When a patient needs a blood thinning medication, a doctor may prescribe Pradaxa. However, the patient should be aware of the possibility of a Pradaxa bleeding injury.

Pradaxa is one of three newer anticoagulant drugs on the market recently to compete with warfarin (Coumadin) and is manufactured by Boehringer Ingelheim Pharmaceuticals.

The reason why Pradaxa and other drugs in its class have been preferable to warfarin is that they have been marketed as requiring less medical monitoring and little change in the diet of the patient.

However, like any blood thinner, Pradaxa carries with it the risk of bleeding injuries. An anticoagulant drug is prescribed to prevent blood clots, but it may have an adverse effect.

Sometimes internal bleeding may occur, putting the patient at risk of hemorrhage and possible death. Pradaxa’s anticoagulant effect, until very recently, had no antidote.

One benefit of warfarin is that in a case of excess bleeding, vitamin K can be administered to help reduce warfarin’s effect and get the bleeding under control.

Pradaxa has been on the market for several years, but it wasn’t until late 2015 that Praxbind, a Pradaxa bleeding injury antidote, was granted approval by the Food and Drug Administration.

Pradaxa Adverse Event Reports

Those five years in between approval and the arrival of Praxbind onto the market was filled with hundreds of adverse event reports connected to Pradaxa.

Within the first three months after Pradaxa’s approval in 2010, the FDA fielded over 300 reports of Pradaxa-related bleeding events, including gastrointestinal bleeding as well as other bleeding complications.

In the first year alone, more than 260 deaths were reported in conjunction with Pradaxa treatment, including gastrointestinal bleeding, hemorrhage and stroke. The Institute of Safe Medication Practices reported that, in 2011, Pradaxa was linked to more deaths than any other drug it reviewed.

Just one year after Pradaxa’s approval, the FDA issued an official warning notifying the public of the serious risks of a Pradaxa bleeding injury and the possibility of a life-threatening situation.

Many families have filed Pradaxa lawsuits against maker Boehringer Ingelheim. They accuse the drug maker of failing to provide adequate dosing information and misrepresenting the safety and effectiveness of Pradaxa in relation to warfarin.

They also believe that Boehringer Ingelheim should not have released Pradaxa at all without a proper antidote.

In May 2014, the company agreed to settle over 4,000 state and federal claims by paying over $650 million in settlements.

Symptoms of a Pradaxa Bleeding Injury

Symptoms of a Pradaxa bleeding injury can include abnormal bruising, frequent nose bleeds, bleeding from the gums, discolored urine, red or black stools and coughing up or vomiting blood.

If you have experienced a Pradaxa bleeding injury, you may be entitled to compensation. An experienced Pradaxa attorney is waiting to discuss your options.