The recent approval of Pradaxa (generic: dabigatran) by the U.S. Food and Drug Administration (FDA) has simultaneously become the subject of increasing criticism and concern. Not only has the anti-blood clotting medication been associated with the development of internal bleeding, but it has seemingly rendered medical intervention irrelevant in certain populations. Subsequently, Pradaxa’s lack of a reversal agent makes it extremely difficult for doctors to address adverse bleeding complications.
Pradaxa was introduced by Boehringer Ingelheim, a pioneer within the pharmaceutical industry, on October 19, 2010. Prior to being released, however, Pradaxa was approved by the U.S. Food and Drug Administration (FDA) to assist in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Having demonstrated the ability to reduce the risk of such adverse events, Pradaxa was dispensed to approximately 86,000 people by outpatient retail pharmacies within months of being released.
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, the pharmacodynamics of direct thrombin inhibitors may be responsible for a variety of associated complications with varying degrees of severity. Subsequently, severe episodes of internal bleeding have recently been linked to the use of Pradaxa. Dabigatran, the mechanism in which Pradaxa prevents blood clots, may adversely affect the coagulation process that is intended to stem the flow of blood in adverse situations. It is believed that Pradaxa may render the entire process of coagulation irrelevant, making it nearly impossible for the blood to clot in times of need. The absence of the coagulation process may demonstrate an increased propensity for internal hemorrhaging.
Of significant concern, however, is the use of Pradaxa in elderly patients. Imbalance and falls are common in this population, and internal hemorrhaging resulting from minor trauma may occur with increasing frequency. Should this happen, Pradaxa may prohibit the clotting cascade from creating a beneficial blood clot. Without any means of preventing the displacement of blood, internal hemorrhaging my lead to severe, life-threatening complications.
Compounding the already ambiguous situation even further, is the distinct lack of a reversal agent in Pradaxa. There is currently no effective antidote to reverse the anticoagulant effect of dabigatran in the event of an emergency. As a direct thrombin inhibitor, Pradaxa exerts its mechanism of action at the very end of the coagulation cascade, rendering many treatment options ineffective. With no way to reverse the anticoagulant effect, doctors may not be able to control adverse bleeding events, making medical intervention much more difficult.
The lack of a reversal agent may turn a routine injury into a severe, life-threatening complication. This has recently been witnessed in the 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 treatment. 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.
Do I Have a Pradaxa Lawsuit?
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