In October of 2010, the Pradaxa drug was approved in the United States by the Food and Drug Administration (FDA) as a viable medical means to prevent stroke in patients suffering from atrial fibrillation. As the most common heart condition around the world, the irregular rhythmic condition of the heart known as atrial fibrillation is one that has been overdue for a medical solution. However, the one that was provided to patients has proven to be more problematic than helpful.
Patients suffering from atrial fibrillation often take blood-thinning medications to ease the condition, and the most common drug that is used for the medical problem has long been Warfarin. In fact, Pradaxa was the first FDA-approved drug designed to treat the problem in almost 60 years. However, the approval may have come too soon, as just more than a year later more than 250 reports were made of fatal bleeding among patients taking the drug. The problem is so widespread, in fact, that its side effects have led to global advisories warning against the problems induced by Pradaxa. Updates have been made to the drug's labeling in both Europe and the United States. Australian and Japan have each issued their own set of warning advisories against the drug as well.
To prevent against future problems of bleeding, the FDA required Boehringer Ingelheim, the German manufacturer of Pradaxa, to re-label the drug. However, as of January 2012, only minimal changes have been made to Pradaxa's labels and the warnings issued on the label do little to suggest the true danger of the potential bleeding problems that the drug can induce. Furthermore, the label provides no information as to the fact that there is no reversal agent that can be used to stop the adverse side effects once they have begun. In essence, Pradaxa warning labels remain insufficient as they are missing what is referred to in the medical field as a "black box warning." The Food and Drug Administration has not yet recalled the product either.
Pradaxa is not the first of pharmaceutical drugs to come with negative side effects. Rather, it is just one in a long line of defective products that have made their way into the medical market despite the adverse risks they carry. While some of these dangerous products have been recalled, others have not. Either way, there is great potential for injury, illness, and even wrongful death when these types of drugs are manufactured, sold, and taken by unsuspecting users.
At Lanier Law Group, P.A., we are here to help those who have been harmed by the defects of a drug. A North Carolina personal injury lawyer from our firm can review your case and help determine how to best move forward within the legal system. If a defective drug has left you injured or ill, then do not wait to contact a North Carolina defective product attorney from our firm today.