In October of 2010, the Food and Drug Administration approved use of Pradaxa (dabigatran) to treat patients diagnosed with atrial fibrillation not caused by a heart valve problem. Atrial fibrillation occurs when part of the heart does not beat the way it should. This condition often causes blood clots to form and leads to an increased risk of stroke and death. Pradaxa is part of a class of drugs known as direct thrombin inhibitors. These drugs prevent blood clots from forming in the body by constraining the enzyme which causes blood cells to clot. Because of this action, Pradaxa is also referred to as an anticoagulant.
Shortly after Pradaxa was approved for treatment of atrial fibrillation, numerous cases of adverse side effects began to surface. The most common and serious side effect reported is internal bleeding.
Symptoms of Pradaxa internal bleeding include:
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Unexpected bleeding or unusually long lasting bleeding
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Severe or uncontrollable bleeding
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Pink or brown urine
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Red or black stools
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Bruises with unknown cause
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Blood clots and coughing up blood
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Blood in vomit or vomit with “coffee grounds” consistency
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Unexpected pain, swelling, joint pain, headaches, dizziness, weakness
A Pradaxa recall has not yet been reported; however, the FDA issued a safety communication in December 2011 notifying the public that an investigation of these internal bleeding reports is in progress.
Other adverse reports associated with use of Pradaxa include gastrointestinal bleeding, brain hemorrhaging, kidney bleeding, heart attack, and even death.
If you or a loved one suffered internal bleeding or any of the symptoms listed above after taking Pradaxa, your injuries may have been caused by Pradaxa. To have the facts of your case reviewed, contact the experienced dangerous drug attorneys at Spangenberg Law Firm by calling (877-696-3303) or by filling out the form to the right. There is no cost for receiving consultation and your information will be held confidential.
