Researchers from the American Stroke Association have decided to undertake studying the safety of Pradaxa and other new generation blood thinning medications. Experts hope to understand the
side effects of anticoagulants on the heart and the risk of stroke. The need for the study is largely due to the increasing number of reported adverse side effects of Pradaxa and other medications.
Pradaxa was approved by the U.S. Food and Drug Administration in October of 2010 for the treatment of atrial fibrillation not caused by a heart valve problem. It is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing the enzyme that causes blood cells to clot.
Atrial fibrillation is a condition that occurs when part of the heart does not beat properly. This condition often causes blood cells to clot together. If the clots travel to the brain, stroke may occur, or if the clots travel to the lungs, pulmonary embolism may occur. Doctors typically prescribe new generation blood thinners like Pradaxa because they are thought to perform better than warfarin, an older blood thinner.
Since the release of Pradaxa, the FDA has received numerous reports claiming that Pradaxa causes a number of serious adverse side effects. Some include internal bleeding, brain hemorrhaging, gastrointestinal bleeding, heart attack, and death.
Cleveland Clinic researchers conducted a study comparing the risk of heart attack while taking Pradaxa with the heart attack risks of taking warfarin. The results showed that Pradaxa users faced a 33% higher risk for heart attack or signs of heart disease than did warfarin users.
The FDA has not issued a recall despite the large number of reported
side effects of Pradaxa. The agency did, however, issue a safety announcement on December 7, 2011 stating that they have undertaken an investigation of internal bleeding reports.
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