Pradaxa blood thinner has been linked to an increased risk of serious bleeding complications.

Pradaxa was approved by the FDA in 2010 to reduce the risk of stroke in patients with atrial fibrillation, an irregular heartbeat marked by erratic functioning of the heart chambers.

Blood clots are more common among people with atrial fibrillation because the heart beats too fast and inconsistently to properly push all of the blood out of the heart. In fact, people with atrial fibrillation are known to have an increased risk of stroke — five times that of our general population — because the possibility of the blood pooling and allowing a clot to form.

Atrial fibrillation itself is not life-threatening, but the strokes caused by the issue are more likely to be severe, with an increased risk of death or disability from these strokes.

A blood thinner, also known as an anticoagulant, can help reduce the risks of blood clots in people with atrial fibrillation.

Problems with Pradaxa Blood Thinner

Pradaxa, made by Boehringer Ingelheim Pharmaceuticals, belongs to a new class of medications called Direct Thrombin Inhibitors. These new oral anticoagulants (NOACs) tend to induce more uncontrollable bleeding incidents than seen in patients taking warfarin, a blood thinner that has been used relatively safely for more than 50 years.

The FDA received 307 reports of internal bleeding complications from Pradaxa in the medicine’s first three months on the market. More than 260 Pradaxa deaths were reported in the first year because, without an effective Pradaxa bleeding reversal procedure, patients fell victim to internal bleeding, gastrointestinal bleeding, hemorrhaging and stroke.

In 2012, Boehringer Ingelheim issued a warning that Pradaxa blood thinner could cause bleeding that was irreversible because no antidote was available at that time.

In contrast, a patient taking warfarin could have the anti-clotting effects stopped in the event of an accident or need for surgery. All emergency room personnel throughout the U.S. are well-versed in administering an IV dose of vitamin K that effectively stops warfarin’s anti-clotting actions.

For years, the only way to stop Pradaxa’s anti coagulating effects was by flushing the blood through dialysis, which can take hours and can result in the patient needing multiple blood transfusions. The combination of complex treatments, the time it takes to rid the body of Pradaxa, and whatever medical issue brought the patient to the hospital in the first place can create a perfect storm potentially leading to a life-threatening situation.

Despite allegedly having an antidote available for years, Boehringer Ingelheim didn’t introduce the Pradaxa antidote until 2015. Known as Praxbind, the antidote was years too late for Pradaxa blood thinner patients who endured life-threatening bleeding events.

By the middle of 2014, Boehringer Ingelheim agreed to a $650 million settlement involving 4,000 state and federal lawsuits regarding injuries and deaths allegedly due to their Pradaxa blood thinner. The company did not admit wrongdoing in the terms of that settlement.

If you or someone you love has suffered serious bleeding injuries or death as a result of taking Pradaxa blood thinner, you could be eligible for compensation through legal representation.