Having been prescribed for only a short period of time, Pradaxa has become one of the premier blood thinning agents on the U.S. market. However, recent studies suggest that Pradaxa may irreversibly inhibit the blood clotting cascade responsible for healing injuries to the blood vessels. The debate as to whether Pradaxa benefits outweigh their corresponding risks continues to perplex the medical community. According to a recent audit of adverse bleeding events, the risks of Pradaxa are to be considered extremely serious.
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.
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.
While Pradaxa does exhibit an increased propensity for the inhibition of stroke and blood clots, it may coincide with equally dangerous complications. Pradaxa may irreversibly interfere with the blood clotting cascade responsible for the development of blood clots. Therefore rendering blood clots nearly nonexistent. The inhibition of the blood clotting process may turn routine injuries into severe, life-threatening complications. It is usually the blood clotting cascade the heals ruptured blood vessel walls, but if blood is not allowed to coagulate, there is nothing to stop the displacement of blood.
A group of hematologists in New Zealand, concerned by what they were witnessing in the short time Pradaxa had been available, initiated a review that was done in collaboration with the Haematology Society of Australia and New Zealand. Their results were published in the Journal of the American College of Cardiology. The review panel identified 78 bleeding episodes over the two-month review period, including 44 cases handled by the panelists. Of the 44 cases with which the panelists were intimately familiar, 12 were severe.
Perhaps just as shocking as the bleeding episodes, were several factors that led to the adverse events in the first place. One of the major factors contributing to the bleeding episodes in this study were prescribing practices. Panelists witnessed Pradaxa be prescribed to those diagnosed with impaired renal functions. Impaired renal function makes it difficult for the body to clear the active, blood-thinning agents from the body, which increases the chance that a bleed will become severe. Approximately 58% of the subjects in this trial exhibited at least moderate forms of renal impairment.
Compounding the ambiguous situation even further, is the lack of a reversal agent that is usually present in these type of medications. For example, doctors can administer agents specifically designed to counter-act warfarin, allowing the blood to clot and reducing the risk that the bleed will continue. However, Pradaxa has no such reversal process available. The recent death of an 83-year-old man revealed that Pradaxa patients who suffer from injuries are at an increased risk of severe bleeding complications.
The man injured himself in a routine fall, in which he was taken to the hospital for medical intervention. 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 met with difficulty. Subsequently, doctors were unable to stop the bleeding and the man passed away.
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.