Pradaxa® (dabigatran)
           We are currently investigating and evaluating bleeding injuries associated with the use of Pradaxa®, an anti-clotting medication approved to prevent the formation of blood clots in patients with atrial fibrillation not caused by cardiac valve deficiencies. Atrial fibrillation, or A-Fib, as it is commonly known, occurs when the atrial chambers of the heart (the smaller, upper chambers) beat in an irregular fashion so that they are rhythmically out of sync with the lower, larger chambers of the heart – the ventricles. A-Fib can be caused by numerous conditions.

            What is Pradaxa®?
            Pradaxa® is an anti-blood-clotting drug that was approved in October 2010 by the FDA for treatment of patients with A-Fib not caused by cardiac valve deficiencies. Pradaxa® is considered an alternative to Warfarin (Coumadin®) but, according to its manufacturer, without the need to conduct regular blood testing to monitor the patient’s level of anti-coagulation. However, there is no effective anti-dote to reverse the anticoagulative effects of Pradaxa®. Therefore, unlike Warfarin (Coumadin®), if unintended bleeding occurs, there is no emergency treatment that will readily reverse the anti-coagulation and thereby stop the bleeding.

            Serious Bleeding Injuries Linked to Pradaxa®
           Since its introduction in the US in October 2010, there have been numerous reports of bleeding injuries, most notably hemorrhages, associated with the use of Pradaxa®. Published reports indicate that as of August 2011 – some 10 months since approval – there were 1.1million Pradaxa® prescriptions written for the 371,000 US patients were taking Pradaxa®.

           In December, 2011, the FDA issued a Drug Safety Communication in which it announced that it would undertake a Safety Review of Pradaxa® in order to examine serious bleeding injuries – in particular hemorrhagic strokes which can lead to death and disability. In its Safety Alert, the FDA states:

           "At present, the FDA is evaluating the post-marketing reports of serious bleeding in patients taking Pradaxa submitted to the Adverse Events Reporting System (AERS) database. While serious, even fatal events have been reported, the FDA is analyzing the events to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa. 
           Complicating this analysis, many factors can influence whether or not adverse effects are reported, particularly the length of time a drug has been marketed, whether or not the adverse effect is described in the drug label, and the amount of publicity about an event or safety concern." FDA Safety Alert, December 7, 2011.

           Potential Safety Signal - Serious Adverse Events Reported to the FDA
           Even before the FDA issued its safety alert, at the end of March, 2011, the FDA’s Adverse Event Reporting System (AERS) included over 900 reports of serious adverse events associated with the use of Pradaxa®. These included both abdominal (gastrointestinal) hemorrhages as well as hemorrhagic strokes (bleeding in the brain). Over 60 of these hemorrhages resulted in death. There were 60 additional deaths, 25 reports involving permanent disability and over 500 cases in which the patients were hospitalized. The reports seem to signal that the apparent risk of serious bleeding injuries may be greatest for elderly patients, particularly those who are 80 years of age and older. At the time of these reports, fewer than 300,000 Pradaxa® prescriptions had been dispensed in the US.

           Our Investigation – Our Commitment
We are currently investigating serious injuries associated with the use of Pradaxa®. If you or a loved one suffered a serious bleeding injury while taking Pradaxa®, we want to hear from you. Please complete and submit our E-FORM. We will contact you with 24 hours and if we agree to investigate your case further, we will begin working on it as soon as you formally hire us to do so. There is no out-of-pocket cost – we work strictly on a contingent fee basis which means we only receive a fee if you, or your loved one, receive compensation for the injury.

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