Death of Elderly Patient Linked to Pradaxa

Healthcare officials have become increasingly concerned over the use of Pradaxa (generic: dabigatran) in the last year. However, the recent death of an elderly man, who was on a Pradaxa regimen, has only served to complicate the already ambiguous issue at hand. Subsequently, the elderly patient was admitted to the hospital last year after sustaining minor injuries for a relatively routine fall from a standing position. He was later pronounced dead after CT scans revealed massive hemorrhaging in the brain of the patient. Officials have suggested that the anticoagulation process onset by Pradaxa may have led to the uncontrolled bleeding that led to the patients unfortunate death.

As a flagship medication of world renown Boehringer Ingelheim, Pradaxa was introduced to the U.S. market on October 19, 2010. The U.S. Food and Drug Administration (FDA) approved of Pradaxe to reduce the occurrence of adverse events associated with blood clots and stroke. After only being on the market for a period of three months, 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.

Unfortunately, it is this mechanism of action that has many healthcare professionals worried. They believe that the inhibition of the blood coagulation cascade may coincide with severe, life-threatening complications. The introduction of Pradaxa into the bloodstream may prevent necessary blood clots from forming. Furthermore, failure to produce said clots may turn a minor injury into a severe bleeding complication because of the inability to prevent the displacement of blood from ruptured vessels.

These unfortunate circumstances were witnessed in the death of an elderly patient last year. The patient was admitted to the hospital last year after sustaining minor injuries for a relatively routine fall from a standing position. Upon arriving at the hospital, the man was alert and responsive with a normal neurological exam and a Glasgow Coma Scale score of 15. The initial CT scan showed only small, superficial areas of hemorrhage in his right temporal lobe and left temporal and parietal lobes.

After the passing of only two hours, he developed slurred speech and his neurological state began to deteriorate rapidly. A subsequent CT scan revealed significant progression of the bleeding to the right parenchymal and left frontal portions of the brain.

Despite the use of reversal agents to remove the presence of dabigatran from the patients blood stream, his health continued to deteriorate. Hemorrhaging continued until his entire left hemisphere was bleeding. The patient was then transitioned to palliative care after extensive discussion with his family and died shortly thereafter.

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 revealed that Pradaxa patients who suffer from injuries are at an increased risk of severe bleeding complications.

According to a report issued by Reuters, the number of deaths, in which bleeding was the primary cause, multiplied at an exponential rate. Subsequently, Boehringer Ingelheim has confirmed 260 reports of fatal bleeding among Pradaxa patients worldwide, up from the 50 deaths the company acknowledged at the start of November.

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