Despite Risks, Pradaxa May Become More Popular than Warfarin
An update to Pradaxa labels may increase use over Coumadin (warfarin), in spite of press about hundreds of deaths and thousands of reports of internal bleeding in Pradaxa patients only two years after the anticoagulant was released.
Boehringer Ingelheim announced the Pradaxa label update on June 6. The new label information suggests that Pradaxa is better than warfarin when it comes to the reduction of ischemic and hemorrhagic strokes. This update is based on data from the RE-LY clinical trials which were influential in the FDA’s approval of Pradaxa in October 2010.
Claims that Pradaxa is better than warfarin will appear in the Clinical Studies section of the label. This trial has been maligned by critics who claim that the study was flawed and that the drug should not have obtained approval based on these results.
In the Therapeutics Initiative, a letter from Canadian researchers at the University of British Columbia was published in 2011. In the letter, the researchers state that the RE-LY study results were tainted by biases and errors.
Pradaxa (dabigitran) is the first alternative to warfarin released in decades, and is used to prevent blood clots and stroke in patients who have atrial fibrillation. Soon after its release, Pradaxa’s reputation was tarnished by a high number of reports of uncontrolled bleeding injuries, deaths and serious Pradaxa side effects.
When a patient on Coumadin hemorrhages, the bleeding can be reversed with a dose of Vitamin K, but Pradaxa has no such reversal agent, which has led to serious injuries and hundreds of deaths.
The Pradaxa label update came on the heels of an Institute for Safe Medication Practices (ISMP) report citing that Pradaxa topped the FDA’s list of adverse event reports in 2011. In these reports, Pradaxa bleeding was linked to 542 patient deaths in the United States alone.
Contact a Pradaxa Lawyer
Boehringer Ingelheim is currently the defendant in a number of Pradaxa lawsuits filed by people who suffered serious injury or the loss of a loved one while taking Pradaxa. In these suits, dangerous drug lawyers claim that the company was negligent in promoting the drug as better than warfarin without warning of the risk of serious bleeding events associated with Pradaxa. If you have suffered injury or the loss of a loved one as a result of taking Pradaxa, you may be entitled to substantial compensation in a pharmaceutical product liability lawsuit. Contact a Pradaxa lawyer today to learn more about your rights in a free legal consultation.