FDA Safety Review of Pradaxa

Boehringer Ingelheim, maker of Pradaxa, has admitted to knowledge of 260 Pradaxa bleeding deaths worldwide from March, 2008 through October, 2011, after originally claiming only about 50 deaths. Now the U.S. Food and Drug Administration (FDA) is conducting a safety review of the drug to determine if it is more dangerous than the agency believed when it granted approval.

The FDA approved Pradaxa based on the results of a large clinical trial which was sponsored by Boehringer Ingelheim. According that trial, Pradaxa should carry about the same risk of serious bleeding events as the older drug warfarin. But the FDA is now questioning whether Pradaxa carries a higher risk of dangerous bleeding events than indicated by the study. It is evaluating post-market reports of Pradaxa bleeding events which have been submitted to its Adverse Events Reporting System (AERS) database.

So far, the effectiveness of Pradaxa is not in question, and the FDA cautions against going off the medication without talking to your doctor and getting an alternative prescription such as warfarin. People with nonvalvular atrial fibrillation (AFib) have a very high risk of stroke if they do not take some kind of anticoagulant to prevent it.

If you or someone you love has been injured by Pradaxa, please call our Pradaxa injury attorney at 1-877-LOSS-RECOVER (567-7732) or submit an online questionnaire. The initial consultation with a Pradaxa injury attorney is free of charge, and if we agree to handle your case, in most cases we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds. In many cases, a personal injury lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.