Pradaxa (dabigatran etexilate) Injury Information
Pradaxa is a blood thinning (anticoagulant) prescription medication used to lower the chance of stroke in individuals with atrial fibrillation. Pradaxa was approved by the FDA in October 2010 and is manufactured by the Germany-based pharmaceutical company Boehringer Ingelheim. On December 2011, the FDA initiated an investigation into serious bleeding events associated with Pradaxa to determine whether excessive bleeding in patients taking Pradaxa is more common than would be expected.
The Journal of the American College of Cardiology published a multicenter prospective study which concluded patients using Pradaxa experience a significant increase in the risk of bleeding or thromboembolic complications compared with patients treated by way of uninterrupted warfarin therapy. Lakkireddy D, et al. Feasibility and Safety of Dabigatran versus Warfarin for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation. J Am Coll Cardiol 2012; 59. An article published in the New England Journal of Medicine expressed the concern that the lack of an effective reversal agent for patients taking Pradaxa should not be underestimated. Harper P, Young L, Merriman E. Bleeding Risk with Dabigatran in the Frail Elderly. N Engl J Med 2012; 366;9.
No Known Reversal Agent or Antidote
Unlike other blood thinners, such as Coumadin/Warfarin, there is no known reversal agent or antidote for Pradaxa, therefore, Pradaxa may cause excessive and serious bleeding that sometimes leads to death. Schlichter Bogard and Denton is currently investigating injuries such as gastrointestinal bleeding, kidney failure, hemorrhagic stroke, and death associated to Pradaxa.
Dangers of Pradaxa
Call the experienced pharmaceutical attorneys at Schlichter, Bogard & Denton if you or someone you loved has taken Pradaxa and have suffered the following conditions:
- gastrointestinal bleeding
- kidney failure
- hemorrhagic stroke; and
- death (as a result of severe or excessive bleeding)
You may be entitled to seek damages for your injuries. Please contact our experienced pharmaceutical drug attorneys for a free consultation.
As always, consult your doctor to learn more about Pradaxa and its associated risks. With all prescription medications, the FDA encourages patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Pleasecontact us today for a free case evaluation and consultation.