Lack of Antidote Makes Pradaxa Dangerous
- Ennis & Ennis News
11/05/2012 - The anticoagulant drug, Pradaxa, may not carry an increased risk of fatal bleeds when compared with other anticoagulants, however the increased fatal risk lies in the fact that once a Pradaxa patient suffers a bleed, there is currently no known antidote to stop the bleeding.
On November 2, 2012 the U.S. Food and Drug Administration (FDA) issued a Safety Communication reporting that according to its studies, Pradaxa does not carry an increased risk of bleeding when compared to patients taking Warfarin. However the report fails to address the lack of a bleeding reversal agent for Pradaxa. A Warfarin bleed, for example, can be reversed with the administration of Vitamin K, whereas a Pradaxa bleed has no such remedy.
The lack of Pradaxa bleed antidote has made this drug quite controversial, especially when there are other anticoagulant options available to patients. Interestingly, the manufacturer of Pradaxa, Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin, reports The New York Times.
In October 2010, Pradaxa was FDA approved for reducing risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. On December 7, 2011 the FDA issued a Safety Communication that it was investigating reports of serious and fatal bleeds in patients taking Pradaxa. In March 2012, the Journal of Neurosurgery published a study that in the event of a traumatic hemorrhage in Pradaxa patients, there is not effective reversal agent. In June 2012, the Institute for Safe Medication Practices reported that Pradaxa had quickly become one of the top drugs to have the most adverse event report filings.
Pradaxa Side Effects Lawyer Accepting Cases
If you or a loved one have suffered serious side effects of Pradaxa, Pradaxa injury or death while using Pradaxa you may be entitled to compensation. Contact the Pradaxa side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Pradaxa attorneys can answer any questions you may have about Pradaxa litigation, Pradaxa side effects, a potential Pradaxa lawsuit or even a possible Pradaxa class action lawsuit. Fill out the Pradaxa lawsuit case evaluation form on this page or call toll free: 1.800.856.6405.