Pradaxa (dabigatran) is a prescription blood-thinning agent intended to reduce the risk of stroke and blood clots in those diagnosed with atrial fibrillation. However, studies suggest that the pharmacodynamics of Pradaxa may be responsible for catastrophic complications. Severe, life-threatening episodes of internal bleeding have become synonymous with the use of Pradaxa.
If you or a loved one has been injured by Pradaxa, you shouldcontact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Pradaxa Lawsuit Overview
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.
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. Boehringer Ingelheim, the company responsible for the development of Pradaxa, acknowledged that 260 cases of fatal bleeding have already been linked to the new stroke prevention medication. Due to the severity of these complications, patients may contact a Pradaxa lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Pradaxa lawsuit.
Pradaxa Side Effects
The following side effects have been linked to the use of Pradaxa:
- Abnormal bleeding
- Blood in urine and stool
- Traces of blood in vomit
- Abdominal pain and discomfort
- Gastroesophageal reflux disease (GERD)
- Digestive tract ulcers
- Serious internal bleeding
- Serious internal hemorrhaging
- Bleeding disorders
- Rectal bleeding
- Cerebral hemorrhage
While these common Pradaxa side effects exhibit mild degrees of severity, they are not considered life-threatening. They are, however, indicative of more severe complications that have become synonymous with Pradaxa treatment.
Recent studies suggest that Pradaxa may be responsible for several bleeding complications with varying degrees of severity. 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. Depending on where it occurs, internal bleeding may result in death and cardiac arrest if treatment is neglected.
Contradictory to the reports associated with internal bleeding, scientific literature suggests that Pradaxa may worsen complications that it was intended to treat. According to recent studies, Pradaxa may not have a significant role in the prevention of blood clots. Subsequently, the clots that Pradaxa was intended to treat remain a severe, life-threatening problem. Blood clots may progressively worsen and eventually evolve into a pulmonary embolism or deep veinous thrombosis (DVT), each of which may result in fatal circumstances.
Higher Risk of Acute Coronary Events
According to an article published by the American Medical Association, the introduction of dabigatran may result in severe complications. To better determine the effects of dabigatran, researchers reviewed PubMed, Scopus, and the Web of Science for randomized controlled trials of the generic drug that acknowledged the presence of myocardial infraction (MI), otherwise known as acute coronary syndrome (ACS). Upon examining the data, researchers discovered that the use of dabigatran is associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against several controls.
ACS, or MI, is synonymous with a heart attack. A heart attack occurs when blood flow to a part of your heart is blocked for a long enough time that part of the heart muscle is damaged or dies. In the event of severe MI and ACS, patients may be unable to compensate for the damage done to the heart and suffer from a fatal event.
Institute for Safe Medication Practices Report
According to a fourth quarter 2010 adverse drug event report issued by the Institute for Safe Medicine Practices (ISMP), Pradaxa has become the subject of several safety concerns. Within just weeks of its approval in October 2010, Paraxa, approved to reduce the risk of stroke in patients with atrial fibrillation, moved to the top of their adverse event rankings, with more reports than 98.7% of the drugs they monitor on a regular basis. The predominant reported adverse effects revolved around the drug’s central pharmaceutical purpose, inhibiting the body’s blood clotting function. However, the events reported were divided among two distinct conclusions. Several reports indicated that Pradaxa rendered the coagulation process irrelevant. The body’s inability to clot when necessary resulted in severe, life-threatening hemorrhages. However, contradicting reports suggested Pradaxa had an insignificant affect on the clotting process. Thus, Pradaxa may have resulted in adverse thromboembolic events such as pulmonary embolism and deep vein thrombosis.
Do I Have a Pradaxa Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Pradaxa lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Pradaxa, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.