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Recent Study Suggests an Increased Risk of Acute Coronary Events When Taking Dabigatran (Pradaxa)

Dabigatran etexilate was approved by the U.S. Food and Drug Administration (FDA) in 2010 to assist in the prevention of stroke and systemic embolism with those who have already been diagnosed with nonvalvular atrial fibrillation (AF). While original dabigatran studies indicate a 34% decrease in the occurrence of stroke and systemic embolism compared to warfarin, a significant relative increase of myocardial infraction (MI) was acknowledged. However subsequent reviews revealed that the additional events of stroke, bleeding, and MI were not as high as originally perceived to be. To better understand the ambiguous side effects that coincide with dabigatran use, a comprehensive study was established to systematically evaluate the risk of MI and acute coronary syndrome (ACS) with several clinical indications.

Dabigatran, the active ingredient found in the popular anticoagulation medication 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 months have witnessed dabigatran become the subject of intense criticism. Studies suggest that the pharmacodynamics of dabigatran may be responsible for several complications with varying degrees of severity. While the mechanism of action responsible for such complications remains ambiguous, the medical community remains cautious.

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 MI, otherwise known as acute coronary syndrome. 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.

Researchers reviewed seven trials in which dabigatran was compared to several control arms (warafarin, enoxaparin, and placebo administration). According to data collected from the trials, dabigatran was significantly associated with a higher risk of MI or ACS than the control arms. The data suggested a 1.9% increase in MI and ACS when dabigatran was used. Whereas controls only witnessed a 0.79% increase.

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.

As determined by the recent study published in the Archives of Internal Medicine, Dabigatran (Pradaxa) may be associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against different controls. Subsequently, clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran.

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.

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 1-800-773-0849.

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