Following reports of Pradaxa internal bleeding complications, the U.S. Food and Drug Administration (FDA) has raised concerns about the anticoagulant medication.

Pradaxa (dabigatran), a blood thinner, is prescribed to prevent and treat blood clots, reducing the risk of stroke. It was approved by the FDA in 2010 and manufactured by Boehringer Ingelheim Pharmaceuticals. However, consumer reports quickly came in alleging several serious and life-threatening injuries after taking the medication.

Some of the Pradaxa internal bleeding complications that have been reported by patients after taking the anticoagulant include kidney bleeding, internal bleeding, heart attack, stroke, brain hemorrhage, gastrointestinal bleeding, and death.

Pradaxa Internal Bleeding Complications

Pradaxa, a relatively new blood thinner, is in a class of medications known as direct thrombin inhibitors. This class of medications acts as anticoagulants by inhibiting the thrombin enzyme’s ability to form a clot.

Once the anticoagulant received its FDA approval, it was quickly believed to be a superior blood thinner compared to its competitor, warfarin, also known as Coumadin. One reason for this was that warfarin required patients to monitor and restrict their diet, and undergo frequent and periodic check-ins for blood tests. Pradaxa did not require this same watchful supervision.

However, reports of Pradaxa internal bleeding complications began to rise.  It was not until five years after Pradaxa’s original release that the FDA approved a reversal agent for the medication known as Praxbind. Warfarin, comparatively, had long since had a responsive reversal agent that could reverse uncontrolled bleeding side effects. By taking vitamin K, patients could counteract warfarin’s anticoagulant effects.

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 regarding the safety of taking the anticoagulant medication. There were an additional 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.

Prior to Praxbind’s approval, there was no way to stop internal bleeding or hemorrhage side effects except by flushing Pradaxa out of the body through dialysis. However, due to the length of time this takes, patients often require multiple blood transfusions and sometimes the uncontrolled bleed results in patient death.

Symptoms of hemorrhage and Pradaxa internal bleeding complications include frequent nosebleeds, discolored urine, coughing up blood, vomiting blood, red or black stool, and bruising with an unknown cause.

Pradaxa lawsuits including class action lawsuits have been filed against Pradaxa’s manufacturer alleging severe side effects and allegations that the company mislead consumers about the safety and effectiveness of Pradaxa. Filing a Pradaxa lawsuit can help aid and recover damages suffered including having to take time off from work, financial damages, and medical expenses.