Patients may qualify to file a Pradaxa claim if they sustained dangerous and unexpected drug side effects during their treatment, with internal bleeding complications being a primary concern.

If a patient had experienced uncontrollable internal bleeding during the course of their prescription, then the patient could be eligible for filing a Pradaxa claim against Boehringer Ingelheim, the drug’s manufacturer.

The claims the patient can seek in a Pradaxa claim often include negligence and failure to warn, with the patient alleging Boehringer Ingelheim had failed to warn the general public against these potential complications.

Pradaxa is an anticoagulant, or blood thinner, medication that is typically prescribed to patients suffering from atrial fibrillation or who are at high risk for stroke and other blood clot attacks. Anticoagulants work by inhibiting the body’s clotting mechanism.

While this treatment mechanism prevents the formation of blood clots, it may also put patients at risk for potentially fatal internal bleeding injuries. There is an approved reversal agent in case of internal bleeding called Praxbind, which can reverse the anticoagulant effect of Pradaxa in case of emergency. However, Praxbind was not available for the first several years that Pradaxa was on the market.

Praxbind was approved by the FDA in 2015, which is five years after the drug’s initial release date in 2010. When Pradaxa was approved, it was the first drug to be approved for blood thinning treatment since warfarin in the 1960s.

Before Praxbind was approved in 2015, warfarin was the only primary anticoagulant with an approved bleeding antidote in the form of vitamin K. Furthermore, Pradaxa patients often have to undergo blood transfusions and dialysis to treat internal bleeding complications despite the release of Praxbind.

Not long after Pradaxa was released, patients began reporting uncontrollable internal bleeding and complaining that Boehringer Ingelheim failed to warn against these complications.

Overview of Pradaxa Bleeding Complications

According to the FDA, the agency had received 307 injury reports regarding Pradaxa internal bleeding issues during the first three months on the market. In addition, the FDA noted there were over 260 deaths allegedly caused by Pradaxa during its first year on the market.

The FDA sent out an official warning regarding Pradaxa bleeding complications in December 2011, stating patients should beware of the potential uncontrollable bleeding risk. Patients who may be suffering from Pradaxa internal bleeding should be wary of unusual symptoms including:

• Unknown or Inexplicable Bruising
• Frequent Nose Bleeds
• Bleeding from Gums
• Discolored Urine
• Red or Black Stool
• Coughing up Blood
• Vomiting Blood

Even though these Pradaxa complications are potentially fatal, patients allege Boehringer Ingelheim failed to give proper disclosure. Patients considering filing a Pradaxa claim should determine what kind of internal bleeding injuries they suffered, which can include:

• Internal Bleeding
• Kidney Bleeding
• Gastrointestinal Bleeding
• Brain Hemorrhage
• Death

At this point, thousands of Pradaxa lawsuits have gone to federal court along with individuals claims being filed and processed separately. Patients who want to file a Pradaxa claim could choose to participate in a Pradaxa lawsuit investigation that is being conducted to determine the full scope of liability that Boehringer Ingelheim may be responsible for.