The pivotal safety study of Pradaxa (dabigatran) was the RE-LY clinical trial (Randomized Evaluation of Long-term Anticoagulant Therapy), which found that people taking Pradaxa were slightly more likely to have a heart attack compared to people taking warfarin. However, researchers are now warning that Pradaxa may actually be associated with a 33% increased risk of heart attacks, which is higher than previously thought.
The researchers evaluated the results of seven different studies, with the bulk of their data from the RE-LY trial. The studies involved 30,514 patients who were taking either Pradaxa or a control medication (wararin, a placebo, or enoxaparin).
- People taking Pradaxa had a 33% increased risk of heart attack compared to people taking a control.
- 1.2% of Pradaxa patients suffered a heart attack, versus 0.8% of people taking a control medication.
- When the researchers limited their analysis to the RE-LY data (which compared Pradaxa to warfarin), People taking Pradaxa were 27% more likely to have a heart attack
The researchers concluded that people taking Pradaxa have a higher risk of heart attack compared to people taking other medications. The study was published in the Archives of Internal Medicine in March 2012.
The researchers noted that the increased risk is approximately 0.25% per year on the medication. This could be significant in patients who have other risk factors for heart disease. Over 10 years, this translates to a 5% increased risk of a heart attack.
In February 2012, researchers in Germany also published a study that found Pradaxa was associated with a 33% increased risk of heart attacks. They concluded their study by claiming that the increased risk was “nonsignificant.”
A heart attack (also known as a “myocardial infarction”) is a life-threatening Pradaxa side effect. It occurs when something (usually a blood clot) becomes stuck in a coronary artery, which supplies the heart muscle with the oxygen-rich blood it needs to pump efficiently. During a heart attack, the heart tissue is deprived of oxygen. If circulation is not quickly restored, the heart muscle can become permanently damaged. This can cause heart failure, in which the heart is unable to supply the body with enough blood. Heart attacks and heart failure can cause severe injury, permanent disability, or death.
Heart attacks can also be caused by vulnerable plagues, which are sticky, semi-solid masses of white blood platelets and lipids that grow along the arterial wall. These soft plaques are vulnerable to rupture. When they rupture, they release cholesterol and debris into the bloodstream, which forms a blood clot, blocks blood flow to the heart, and causes a heart attack.
Do I have a Pradaxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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