When we hear the term “irreversible bleeding,” we often think of someone in the hospital “bleeding out,” with fatal consequences.

Sometimes, the cause of irreversible bleeding is unknown. Other times there is a specific catalyst that starts the internal bleeding process.

Since 2010, a new class of drugs has been implicated in cases of excessive bleeding. These cases linked with bleeding complications are sometimes linked with an anticoagulant called Pradaxa.

Lawsuits over Pradaxa irreversible bleeding events numbered more than 4,000 just a few years after its release.

Pradaxa (dagibatran) is manufactured by Boehringer Ingelheim Pharmaceuticals. This anticoagulant medication is used to treat patients who suffer from atrial fibrillation.

Atrial fibrillation occurs when there is an abnormal heart rhythm that causes the heart to contract irregularly. Due to the abnormal contractions, blood clots may form near the heart and potentially lead to stroke.

In addition to treating atrial fibrillation, Pradaxa is also used to prevent deep vein thrombosis, also known as DVT, and pulmonary embolism, also referred to as PE. Both of these conditions may have fatal consequences.

Like other anticoagulant medications, Pradaxa works by interfering with the normal clotting mechanisms in the blood to reduce the risk of blood clots forming.

Pradaxa and the new oral anticoagulant drugs that have recently been approved this decade were developed as an alternative to warfarin (Coumadin) which was the standard oral blood thinner used since the 1950s.

The new drugs were intended to be easier to use and to be more effective. They do not require frequent patient monitoring to determine blood levels of the medication and most times, the medication is issued at standard doses.

Safety information for Pradaxa in its use as a treatment for atrial fibrillation was based on a study called the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) study, which looked at Pradaxa compared to warfarin.

The results of the study showed that taking Pradaxa twice per day at 150 mg was superior to warfarin in its performance. What the study did not show, however, was the potential for Pradaxa irreversible bleeding.

With warfarin, there was an antidote available to reverse the anti-clotting mechanism of the medication and thus restore the body’s natural clotting mechanisms. The reversal agents used were fresh frozen plasma and intravenous vitamin K. Together, these antidotes help to quickly reverse the effects of warfarin and assisted in stabilizing the patient.

For the first five years after it was released, Pradaxa had no antidote to reverse the effects of internal bleeding in the body.

When patients on Pradaxa were hospitalized, there was no way to directly address the Pradaxa irreversible bleeding and physicians used the best methods possible to keep patients stable as they waited for Pradaxa to metabolize out of the patient’s system.

During the time that there was no antidote to Pradaxa available, numerous patients suffered from severe physical damage as a result of Pradaxa irreversible bleeding events, and some even succumbed to death.

Last fall, Boehringer Ingelheim Pharmaceuticals released an antidote to Pradaxa named Praxbind. It is hoped from this point forward that patients will not have to suffer from Pradaxa irreversible bleeding events.

Filing a Pradaxa Irreversible Bleeding Lawsuit

Nearly 4,000 lawsuits were pending against Boehringer Ingelheim in 2014, with plaintiffs claiming the drug was unsafe.

The pharmaceutical company reached a settlement to resolve claims in all of the lawsuits at the time and paid out an average of $160,000 to each of the affected plaintiffs and/or families.

If you or a loved one has suffered from the effects of Pradaxa irreversible bleeding, you may be entitled to legal compensation as a result of your situation.

An experienced Pradaxa attorney can review your case for free and can help you decide if filing a Pradaxa irreversible bleeding lawsuit is right for you.