Pradaxa Treatment May Have Turned a Routine Injury Into a Fatal Hemorrhage

Pradaxa (generic: dabigatran) has recently become a subject of increasing concern in the healthcare community. Compounding the already ambiguous situation is the recent death believed to be linked to Pradaxa use. According to the Journal of Neurosurgery, an elderly man receiving Pradaxa treatment sustained a fatal brain hemorrhage after a routine fall. The journal acknowledges that bleeding complications that the man suffered were do in part to the blood thinning agents found in Pradaxa.

As a product of Boehringer Ingelheim, Pradaxa was developed and introduced as a new molecular entity on October 19, 2010. Following the appropriate regulatory actions, Pradaxa was approved by the U.S. Food and Drug Administration (FDA) because it displayed a propensity to reduce the risk of adverse events associated with blood clots and stroke. Within three months of being introduced to the U.S. market, the revolutionary blood thinning agent was dispensed to approximately 86,000 patients by outpatient retail pharmacies.

Dabigatran, the active ingredient found in Pradaxa, belongs to a distinct group of medications known as direct thrombin inhibitors. As their name suggests, direct thrombin inhibitors prevent the actions of thrombin, a protein responsible for the coagulation of blood. By attaching itself to thrombin, Pradaxa neutralizes the actions exhibited by the protein. Thus, Pradaxa has the inherent ability to thin blood and prevent coagulation, a major component in the prevention of stroke and blood clots.

However, recent critics of the medication believe that the anticoagulation mechanism is irreversible and potentially dangerous. The inhibition of blood clotting interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, preventing both thrombin formation and development of thrombi. In doing so, the body is unable to clot blood when deemed appropriate. Therefore, minor injuries may result in severe complications.

Adding further concern to Pradaxa use is the recent death of an 83-year-old man who used the prescription blood-thinning agent. The man injured himself in a routine fall, in which he was taken to the hospital for medical intervention. Three doctors from the University of Utah monitored and described the worsening condition of the man.

Initially, the patient was fully alert and oriented and could respond to verbal commands, and his neurological exam produced no findings of great concern. CT scans revealed small, superficial areas of hemorrhage in his brain, but within two hours after being admitted to the hospital subsequent scans revealed extensive progression of brain hemorrhaging. Efforts to stop the bleeding were futile and the man soon slipped into a coma and died. “In the event of traumatic hemorrhage in patients receiving dabigatran … there are currently no effective reversal agents” to neutralize the drug, the doctor’s report said.

The bleeding produced by the fall manifested itself into a severe complication. The anticoagulation process exhibited by Pradaxa prevented his body from clotting blood to stop the bleeding. The presence of Pradaxa in the blood also made it difficult for doctors to induce a clot of their own.

Do I Have a Pradaxa Lawsuit?

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If you or a loved one has been injured by Pradaxa, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.