Boehringer Ingelheim Pharmaceuticals, Inc. Recalls One Lot of Pradaxa due to Packaging Defects
- Ennis & Ennis News
11/16/2012 - On November 7, 2012, Boehringer Ingelheim Pharmaceuticals, Inc. manufacturer of the Pradaxa, issued a recall on one lot of Pradaxa. Pradaxa is an anti-coagulant used to reduce the risk for stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The recall was prompted due to a potential packaging defect that could compromise the bottle integrity, making it susceptible to moisture, which could impair the quality and effectiveness of the drug thereby increasing the risk of ischemic stroke. The affected lot number is 201900, with expiration date January 2015.
Patients should immediately contact their pharmacist for replacement at no charge and not interrupt the prescribed therapy.
Controversy Regarding Pradaxa
On October 19, 2010, Pradaxa was FDA approved. Pradaxa quickly became one of the top adverse events reported drugs filed with the FDA, thereby putting it onto the FDA’s radar. On December 7, 2011, the FDA issued a Safety Communication reporting that it was investigating reports of serious and fatal bleeds in patients taking Pradaxa.
While Pradaxa can make its users more susceptible to dangerous bleeds, the primary concern is that there is no way to stop the bleed once it begins. In fact in May 2012 The Journal of Neurosurgery reported that researchers at the University of Utah raised serious concerns noting in the event of a traumatic hemorrhage in patients receiving Pradaxa, there were no effective reversal agents. As a result, Boehringer Ingelheim is facing many lawsuits wherein patients suffered dangerous, and sometimes fatal, bleeds.
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.