Pradaxa (dabigatran etexilate mesylate) is a blood-thinning medication (anticoagulant) manufactured by Boehringer Ingelheim. This medication is prescribed to reduce stroke risk and blood clots in patients with atrial fibrillation that is not caused by heart valve problems. Food and Drug Administration (FDA) issued a drug safety communication indicating a safety review would be undertaken by the agency to assess post-market reports linking serious bleeding events with the use of Pradaxa. Atrial fibrillation is a rapid and irregular heart condition which results in poor blood flow throughout the patient’s body. market since it was approved for sale by the Food and Drug Administration (FDA) in October 2010. In January 2012, Boehringer Ingelheim modified the Prescribing Information for Pradaxa to include a warning on the increased risk of bleeding which may result from taking the drug. This medical condition is typically controlled and treated with blood-thinning medications such as Pradaxa. The drug is widely used for treatment of atrial fibrillation in the U. The FDA reports that from October 2010 through August 2011, approximately 1.1 million prescriptions of Pradaxa were distributed. The warning includes an extremely concerning statement indicating that “Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.” The following are adverse reactions that may be associated with taking Pradaxa: 1. Furthermore, during the same time period, approximately 371,000 patients obtained prescriptions for this drug from U. Risk of serious bleeding Several studies have raised concerns regarding the increased risk of serious bleeding resulting from the use of dabigatran drugs such as Pradaxa: 2. Risk of heart attack or acute coronary events Peer-reviewed journal articles have also cited troubling evidence of an increased risk of developing acute coronary syndrome or other serious heart conditions as a result of taking Pradaxa: This law firm specializes in dangerous drug cases like Pradaxa. If you have been injured or have lost a loved one in connection with the use of Pradaxa, please contact us at 1.800.247.1623 or [email protected] a free consultation regarding your legal rights. amoxicillin 500 mg dose An Alvarado woman filed a lawsuit claiming she has been left with severe and permanent injuries after a surgeon allegedly failed to remove a cancerous tumor and removed a portion of her pancreas instead. 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