Pradaxa® Lawyers Embolden Injured Pradaxa Patients to Take Legal Action

More than 250 cases of internal bleeding in patients using Pradaxa® (dabigatran etexilate) for atrial fibrillation have been reported worldwide, many of them resulting in fatal hemorrhage. Although Pradaxa is marketed as a more convenient choice than traditional treatment with Coumadin® (warfarin), there is no available measure to stop bleeding in patients using Pradaxa. In patients using warfarin, Vitamin K injections can stop internal bleeding and hemorrhaging, but the lack of a reversal agent to stop bleeding in patients using Pradaxa warrants significant concern on the part of physicians and patients.

The Pradaxa lawyers at the Florida personal injury law firm of Searcy, Denney, Scarola, Barnhart & Shipley PA routinely represent patients who have experienced internal bleeding or other serious side effects as a result of Pradaxa. The dangers of internal bleeding and other serious problems caused by Pradaxa use are well-documented. For example:

  • Pradaxa Death: An otherwise healthy elderly man being treated for atrial fibrillation with Pradaxa died from a brain hemorrhage following a ground-level fall, the Journal of Neurosurgery (March 6, 2012) reports. Doctors in the Department of Neurosurgery at the University of Utah reported extensive progression of brain hemorrhage within two hours of arrival and cited a lack of any reversal agents for traumatic bleeding in patients using Pradaxa.
  • Pradaxa Side Effects: The RE-LY® trial, the pivotal study comparing Pradaxa to warfarin use in 18,000 patients, was conducted by Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. from November 2005 to April 2009. The trial revealed that the most frequent adverse reactions leading to discontinuation of Pradaxa were bleeding, gastrointestinal events and gastritis-like symptoms. In addition, patients who received Pradaxa had a higher risk of heart attack than those who received warfarin.
  • Pradaxa Hemorrahages: In December 2011, the U.S. Food and Drug Administration (FDA) began to evaluate post-marketing reports and investigate claims of bleeding in patients taking Pradaxa from its MedWatch Safety Information and Adverse Events Reporting System (AERS). The Institute for Safe Medication Practices stated in January 2012 that “more instances of Pradaxa hemorrhages (at least 505) were reported to the AERS during the first quarter of 2011 than were reported in association with any other drug monitored by the group.”
  • Pradaxa Storage: In March 2011, the FDA advised that Pradaxa be dispensed and stored only in its original bottle or blister package due to the potential for product degradation from moisture and loss of potency. The drug should not be dispensed in a generic bottle or stored in pill boxes or pill organizers. The FDA reported concerns that Pradaxa users and pharmacies may not be aware of these storage and dispensing requirements, which may affect drug efficacy.

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