The U.S. Food & Drug Administration (FDA) is allowing a label change for the new anticoagulant Pradaxa, which may propel usage of the controversial drug beyond that of Coumadin (generic: warfarin).
Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
June 11, 2012 – The new Pradaxa label update was announced by Boehringer last week, indicating that new information will be added to the drug’s packaging which suggests that it is better than Coumadin at reducing the risk of ischemic and hemorrhagic strokes. The new information is based on conclusions drawn from the RE-LY clinical trials, which were used to garner approval for Pradaxa in October 2010. The updated verbiage will appear in the Clinical Studies section of Pradaxa’s labeling.
Yet despite the seemingly good news for Pradaxa, a growing movement within the medical community has called the validity of RE-LY into question, arguing that the drug should never have been approved based on the results of the study. In a letter published last year in the Therapeutics Initiative, researchers from the University of British Columbia criticized RE-LY, indicating that it contains fundamental errors and biases that severely skewed its results. While the trial used a double-blind comparison between two doses of Pradaxa, a non-blinded comparison was used between Pradaxa and Coumadin.
Pradaxa is marketed by Boehringer as a superior alternative to Coumadin because it supposedly requires less patient monitoring. Unfortunately, since its release, there have been a shocking number of adverse event reports involving severe hemorrhages among Pradaxa users, including hundreds of deaths from the drug. Among users of Coumadin, internal bleeding side effects can be addressed with a single dose of Vitamin K. Pradaxa has no such antidote or quick fix once internal bleeding events occur.
The new label changes were announced just days after a report by the Institute for Safe Medication Practices (ISMP) found that Pradaxa side effects topped the FDA’s list for most adverse event reports (AERS) in 2011. The report identified Pradaxa as the likely cause of at least 542 patient deaths in the United States, and more cases of severe hemorrhaging than any other medication.
As the controversy surrounding Pradaxa’s internal bleeding side effects has grown in recent months, so too has the number of lawsuits filed over the drug increased dramatically. The vast majority of these complaints allege that Boehringer was negligent in failing to adequately research their drug, or warn about the risk of serious and potentially life-threatening internal bleeding events associated with Pradaxa use.
Do I Have a Pradaxa Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.