Protecting the Rights of Victims Injured by Dangerous Pharmaceuticals
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 Florida Pradaxa drug lawyers at the personal injury law firm of Searcy, Denney, Scarola, Barnhart & Shipley, P.A. 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 catastrophic problems caused by Pradaxa use are well-documented. For example:
- Pradaxa deaths: 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 reported on March 6th, 2012. 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 were treated with 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.
Consult with Our Experienced Florida Pradaxa Drug Law Firm
If you sustained internal bleeding, hemorrhaging or other medical problems as a result of Pradaxa use, take action to protect your health and your legal claim. Call Searcy Denney at 800.780.8607 to schedule a free evaluation of your claim by our Florida Pradaxa Drug attorneys. You can also fill out our consultation form.