As a new generation oral anticoagulant, Pradaxa (dabigatran) gave high hopes to patients and physicians for a superior blood thinning medication.

Released in 2010, Pradaxa was approved to prevent stroke in patients with atrial fibrillation, an abnormal heart rhythm. It is also used for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Pradaxa was the first new blood thinning medication to be developed as an alternative to warfarin (Coumadin), an oral anticoagulant that was the standard medication for the last sixty years.

Warfarin required frequent patient monitoring and required patients to follow certain dietary restrictions while they were taking the medication. Pradaxa eliminated the need for the frequent monitoring and dietary restrictions, which was embraced by physicians and patients alike.

Pradaxa and Internal Bleeding

While it was seen as a step forward in the use of oral anticoagulant treatment, Pradaxa has not been without controversy and potential side effects.

As with any blood thinning medication, warfarin included, Pradaxa use causes an increased risk of bleeding, particularly gastrointestinal bleeding and brain bleeds.

The risk of bleeding comes from the mechanism of action of anticoagulants themselves. Blood thinning medications are designed to prevent blood clots by interfering with the body’s natural clotting mechanism. Interfering with this process prevents blood clotting, which is good for preventing things like stroke, DVT and PE.

However, there are times when the body needs to form a clot in order to stop bleeding. With Pradaxa, once the bleeding in the body starts, it cannot be stopped until the effect of the medication wears off.

Warfarin did have an advantage over Pradaxa in that the bleeding was able to be reversed in patients. Fresh frozen plasma (FFP) and intravenous vitamin K are used as an antidote to stop the bleeding and reinstate the body’s clotting mechanism. Pradaxa had no such intervention for its first five years on the market.

Currently, Praxabind has been released by Boehringer Ingelheim as a reversal agent medication to stop bleeding events caused by Pradaxa. However, many patients suffered severe bleeding complications when such an intervention was not available.

Symptoms of Pradaxa Internal Bleeding

Symptoms of Pradaxa internal bleeding depend on the location of the bleed. Symptoms of the two most common types of Pradaxa internal bleeding are as follows:

Brain Bleeds: Headache, nausea, vomiting, extreme fatigue, confusion, transitory loss of vision, feeling weak or numb on one side of the body, difficulty speaking, seizures, loss of consciousness.

Gastrointestinal Bleeding: Abdominal pain, rapid heartbeat, breathlessness, clammy skin, increased thirst and dry mouth, reduced urination, extreme fatigue, weakness or lightheadedness, confusion, vomiting blood (red or like coffee grounds), bloody or black stool.

Filing a Pradaxa Internal Bleeding Lawsuit

Patients who suffered irreversible brain bleeds or gastrointestinal bleeding while on Pradaxa before the antidote was developed felt that the drug manufacturer did not do enough to warn patients about the severity of the potential side effects.

Many patients have taken legal action against Boehringer Ingelheim, Pradaxa’s manufacturer for this very reason.

By 2014, over 4,000 lawsuits were filed against Boehringer Ingelheim, and the company paid $650 million to settle the lawsuits that were pending at the time. The manufacturer, however, admitted no wrongdoing and there has not been a label change to the drug. Many pending lawsuits remain.

If you or a loved one has suffered internal bleeding from Pradaxa, you may be eligible for legal compensation. A Pradaxa lawyer can review your case for free and can advise you on your legal options.