A recent meta-analysis published in the Archives of Internal Medicine has identified the popular anticoagulant Pradaxa (generic: dabigatran) as being associated with greater odds of myocardial infarction (MI) and acute coronary syndrome than control treatments.
Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
January 10, 2012 – According to researchers at the Cleveland Clinic, among randomized controlled trials for a variety of indications, myocardial infarction and acute coronary syndrome occurred at a substantially higher rate with Pradaxa when compared to control treatments (1.19% versus 0.79%; OR 1.33, 95% CI 1.03 to 1.71).
“Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran,” said Ken Uchino, MD, and Adrian Hernandez, MD, PhD, in Archives of Internal Medicine.
The meta-analysis evaluated Pradaxa as used for:
- stroke prevention in atrial fibrillation (versus warfarin)
- prophylaxis for acute venous thromboembolism (versus warfarin)
- deep venous thrombosis (versus enoxaparin)
- prevention of events in acute coronary syndrome (versus placebo)
The study was conducted to examine the risk of MI and acute coronary syndrome in diverse patient populations who were treated with Pradaxa. For purposes of analysis, individuals taking any dose of the drug were grouped together.
The research involved seven randomized controlled trials that included 30,514 test subjects. The control arms of the study included warfarin, enoxaparin, or placebo. The analysis concluded that Pradaxa was associated with a significantly higher risk of MI and acute coronary syndrome — 0.27% (95% CI 0.04% to 0.50%).
Uchino and Hernandez stated that they were unaware of any pharmacologic mechanism to explain why Pradaxa may increase the risk for MI or acute coronary syndrome. They speculated that it could be due to the medication’s chemical composition, or that the control drugs are better at preventing these conditions than Pradaxa.
“The overall benefit and risk balance of dabigatran use appears to be favorable in patients with atrial fibrillation because of reduction in ischemic stroke,” Uchino and Hernandez wrote. “However, the cardiac risk of dabigatran should be investigated further, especially if it is used in populations at high risk of MI or acute coronary syndrome.”
Do I Have a Pradaxa Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.