Approved by the FDA in October 2010, Pradaxa (Dabigatran) is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., to reduce the risk of strokes and blood clots in people who have atrial fibrillation, a common heart rhythm abnormality. Pradaxa is in a class of anticoagulant medications known as “blood thinners.” Pradaxa is a direct thrombin inhibitor. It prevents the formation of blood clots by counteracting the effects of thrombin, which is responsible for clotting. Boehringer Ingelheim Pharmaceuticals markets Pradaxa as the preferred blood thinner. According to Boehringer, it is easier to dose, requires less monitoring, and is more effective at preventing clots compared to Warfarin (Coumadin). However, unlike Warfarin, Pradaxa’s anticoagulation effect cannot be reversed with vitamin K, significantly increasing the odds that a bleeding event will turn fatal.

As you may know, atrial fibrillation is the most common heart rhythm condition. Patients with this condition typically require blood-thinning medications. Warfarin is one such blood-thinner that is commonly used. Pradaxa is the first alternative to that drug. In November 2010 the drug manufacturer confirmed at least 260 fatal bleeding events in patients taking Pradaxa.

Pradaxa side effects have prompted safety advisories in Japan and Australia and have led to labeling updates in Europe and the United States. The FDA recently required the German pharmaceutical manufacturer Boehringer Ingelheim to update its Pradaxa label after receiving a large number of adverse event reports from consumers. The January 2012 label change added minimal information regarding the dangers of bleeding events and the lack of a reversal agent for Pradaxa.

To date, there have been significant numbers of fatal bleeds reported to the FDA. The lack of a reversal agent is believed to be the cause of the significant number of bleeding-related adverse events. While various reports have linked 260 bleeding deaths to Pradaxa, Boehringer, in an official statement on November 2, 2011, linked about 50 bleeding deaths to Pradaxa, which Boehringer asserted is consistent with expectations from the Pradaxa clinical trials. Earlier this year, the FDA required Boehringer to modify the Pradaxa warning label to reflect the lack of a reversal agent, which, amazingly, had not been included in the original warnings. The FDA is currently evaluating the reports of bleeding deaths and investigating whether the rate of severe bleeding reports is higher than what was seen in the Pradaxa clinical trials. At this point, there is no black box warning for Pradaxa.

If you or someone you care about took Pradaxa and suffered a personal injury or died, you may have a pharmaceutical defect claim against the manufacturer of Pradaxa. We are currently investigating claims of serious injuries and deaths involving Pradaxa. If you need additional information or would like for us to review your potential claim, please contact Roger Smith, a lawyer in our Mass Torts Section, by way of email at Roger.Smith@BeasleyAllen.com or call him at 800-898-2034.