Pradaxa (dabigatran) is a new generation anticoagulant that is used to prevent the formation of blood clots. It works by blocking thrombin, a clotting protein.

Pradaxa is primarily used to treat atrial fibrillation, an abnormal heart rhythm that is linked to an increased risk of stroke if a blood clots form.

Pradaxa and another new generation anticoagulant, Eliquis (apixaban), were developed as an alternative to warfarin (Coumadin) in hopes that these new drugs would be easier to use. Warfarin, though effective, had several disadvantages. Warfarin requires frequent monitoring and is also associated with a number of food and drug restrictions.

According to physicians, the new generation anticoagulants Pradaxa and Eliquis are superior to warfarin in preventing strokes in individuals with atrial fibrillation. Despite its ease of use and superior performance, Pradaxa’s risk of causing major bleeding remains a major concern.

Pradaxa and Bleeding Concerns

The risk of major bleeding was also a concern with warfarin. However, there is an antidote to stop excess bleeding in patients who are taking warfarin. Fresh frozen plasma and vitamin K are given together to work as a reversal agent to stop the bleeding.

At this time, a reversal agent for the new generation of anticoagulants is not available. This makes for a potentially serious situation when anticoagulant-induced bleeding becomes out of control and no Pradaxa antidote is available.

Signs of serious bleeding may not be considered linked to the use of Pradaxa at first, as some signs of serious bleeding may not involve blood directly at all.

Serious signs to watch out for that may indicate a Pradaxa bleeding risk include:

• Black, bloody or tarry stools
• Coughing up blood
• Dizziness or fainting
• Easy or unusual bruising
• Frequent or persistent nosebleeds
• Heavy or prolonged periods in women
• Persistent or unusual fatigue or weakness
• Prolonged bleeding from gums or cuts
• Severe headache
• Unusual pain, swelling or discomfort anywhere in the body
• Urine that is dark or has a pink tint
• Vomit tainted with blood or that looks like coffee grounds

Emergency hospital care can sometimes control the excess bleeding, but in some cases, the situation is too advanced and the severe bleeding can be fatal.

Other Pradaxa Side Effects

Less serious side effects are also common with Pradaxa. Such side effects include:

• Abdominal pain or upset
• Diarrhea
• Heartburn
• Indigestion
• Itching
• Nausea
• Skin rash (mild)

Court Cases Against Pradaxa Manufacturer

Boehringer Ingelheim Pharmaceuticals, the manufacturer of Pradaxa, has been the target of thousands of Pradaxa lawsuits. Those who have filed a Pradaxa bleeding lawsuit have alleged that Pradaxa was not as safe as the aggressive marketing proclaimed and the company did not properly inform consumers of the serious and sometimes life-threatening risks that the drug held.

In May 2014, Boehringer Ingelheim paid $650 million to settle the 4,000 state and federal Pradaxa lawsuits that were active at the time, however, the company denied any wrongdoing.

Individual Pradaxa lawsuits continue to be filed by injured consumers, and there is multidistrict litigation as well. Multidistrict litigation occurs when a number of lawsuits are consolidated and sent to a single court and cases are heard by one judge. This process assists in a more streamlined approach, saving time and resources and assists in more consistent rulings.