Patients who took new anticoagulant Pradaxa and suffered injuries because Pradaxa bleeding reversal was not an option could be eligible for compensation.

In 2010, Pradaxa was approved by the FDA to reduce the risks of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Blood clots occur more frequently in people who have atrial fibrillation because the heart beats so fast and inconsistently that the blood isn’t pushed completely out of the heart. Patients with atrial fibrillation are at an increased risk of stroke that is five times that of the general population. Before a Pradaxa bleeding reversal agent was made available, patients were exposed to serious risks.

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

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

For decades, Coumadin (warfarin) was the only blood thinner on the market. Patients on warfarin need to undergo blood tests regularly to ensure a maintenance dose of the medication is adequate at all times. In the event of an unexpected surgery or accident, warfarin’s anticoagulating properties can be stopped with an IV dose of vitamin K. Emergency room doctors across the country are taught how to stop warfarin’s blood-thinning actions in the event of a bleeding emergency.

A Pradaxa bleeding reversal agent did not become available until years after Pradxa was introduced to the market. Before then, Pradaxa patients were at greater risk of internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhaging, or even death.

A Need for Pradaxa Bleeding Reversal

Pradaxa, made by Boehringer Ingelheim Pharmaceuticals, is in a new class of medications called Direct Thrombin Inhibitors. These new oral anticoagulants (NOACs) tend to induce more problematic bleeding episodes than seen with warfarin.

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 succumbed to internal bleeding, gastrointestinal bleeding, hemorrhaging and stroke.

Pradaxa’s anticoagulating effects can be stopped by flushing the blood through dialysis. Unfortunately, dialysis can take hours and could result in multiple blood transfusions. The combination of this treatment, the time it takes to rid the body of Pradaxa, and the medical issue that brought the patient to the hospital in the first place add up to a life-threatening situation that some patients don’t survive.

The FDA warned Pradaxa patients in December 2011 that the blood thinner presented a serious risk of uncontrollable internal bleeding. Since then, thousands of Pradaxa lawsuits have been filed because patients believed the new anticoagulant was a safe, effective way to prevent blood clots caused by atrial fibrillation.

If you have suffered from a lack of Pradaxa bleeding reversal options, you could benefit from legal representation to receive compensation for lost wages, medical expenses, and pain and suffering.