An increasing number of Pradaxa bleeding complications have quickly led the U.S. Food and Drug Administration (FDA) to raise serious concerns over the anticoagulant medication.

Pradaxa (dabigatran), a blood thinner that was originally approved by the agency in 2010, was quickly blamed for several serious adverse side effects and complications with links to life threatening injuries.

Patients who were potentially injured by Pradaxa bleeding complications may be eligible to file a legal claim if having suffered from any number of the following:

• Kidney bleeding
• Internal bleeding
• Heart attack
• Brain hemorrhage
• Stroke
• Gastrointestinal bleeding
• Death

Overview: Pradaxa Bleeding Complications

Pradaxa is prescribed to prevent and treat blood clots, thus reducing the risks of stroke. Manufactured by Boehringer Ingelheim Pharmaceuticals and approved in 2010, it has been linked to several serious adverse side effects and complications.

In fact, the FDA received 307 adverse event reports filed by Pradaxa patients within the first three months of Pradaxa’s approval. These event reports raised issues of blood thinner safety.

There had also been 260 death reports filed with the FDA within the first year of Pradaxa’s approval. These deaths were allegedly due to gastrointestinal bleeding, stroke, hemorrhage, and internal bleeding.

Pradaxa is a part of a class of medications known as direct thrombin inhibitors. This class of medications act as anticoagulants by directly inhibiting the thrombin enzyme’s ability to form a clot; thus, helping to limit and prevent strokes.

Upon its approval by the FDA, it was marketed as being a superior blood thinner than that of its competitor, warfarin, also known as Coumadin. The reason for this was that warfarin required patients to monitor and undergo diet restriction, in addition to undergoing frequent and periodic blood testing, while Pradaxa did not require such a watchful eye.

However, Pradaxa bleeding complications began to be reported. All anticoagulant medications come with a bleeding risk, but Pradaxa lawsuits are being filed against Boehringer Ingelheim over allegations that the company misled consumers regarding Pradaxa’s safety and effectiveness.

In fact, not until Oct. 16, 2015, five years after Pradaxa’s approval, did patients have access to the drug’s reversal agent, Praxbind, to help reverse severe internal bleeding effects associated with the drug.  On the other hand, warfarin always provided patients a reversal agent (through the administration of vitamin K) that could help reverse adverse bleeding side effects.

Prior to Praxbind’s approval, there was no way to stop internal bleeding or hemorrhage side effects except by flushing the body of Pradaxa through dialysis. However, due to the length of time this usually takes, bleeding episodes have resulted in multiple blood transfusions for patients and even death.

Symptoms linked to Pradaxa bleeding complications include: frequent nose bleeds, discolored urine, coughing up or vomiting blood, red or black stools, and bruising with unknown cause.

If you or a loved one have suffered from Pradaxa bleeding complications, you may be eligible to file a Pradaxa lawsuit. A lawsuit can help aid and recover damages suffered, such as financial damages, medical expenses, and taking time off from work.