Pradaxa is a prescription anticoagulant approved by the Food and Drug Administration (FDA) for use in the United States in 2010. Pradaxa is manufactured by German company Boehringer Ingelheim. Recently Pradaxa has come under fire because numerous Pradaxa patients have suffered from death or extended hospitalization due to gastrointestinal bleeding, hemorrhagic stroke, and trauma-induced unusual bleeding events caused by Pradaxa.
Pradaxa is prescribed to patients suffering from atrial fibrillation. Prior to the introduction of Pradaxa, the most common treatments for atrial fibrillation in the United States were warfarin therapy, aspirin, or no treatment at all. Boehringer Ingelheim saw an opportunity and void in the market which they sought to fill with Pradaxa.
Many patients who took warfarin for atrial fibrillation complained about the drug because it is considered ‘inconvenient’ in many ways. To name a few, there are extensive dietary restrictions coupled with warfarin use, warfarin patients are required to have frequent blood sampling, there are numerous dangerous interactions between warfarin and other drugs, and finally there is a very specific INR range which patients must stay in for it to be safe and effective.
A major advantage which warfarin has over Pradaxa is its potential reversal agents. In severe bleeding events among patients taking warfarin, there are multiple options for the patients to safely reverse internal bleeding. Patients may supplement their intake with Vitamin K, have plasma infusions, and other factor concentrates that are relatively easy for doctors to monitor with available tests.
Pradaxa, however, does not have any known reversal agent once internal bleeding begins. This is a major concern, and is the grounds for some of the strongest Pradaxa lawsuits. Until early in 2012, Boehringer Ingelheim did not warn patients that Pradaxa has no reversal agent. Once internal bleeding begins in patients taking Pradaxa, they are unable to simply take Vitamin K to stop internal bleeding like warfarin patients can.
After hundreds of people died from internal bleeding while taking Pradaxa, Boehringer Ingelheim was forced to supplement their warning information to explicitly state that Pradaxa has no reversal agent. According to the New England Journal of Medicine, the only reversal agent for Pradaxa internal bleeding is to perform emergency dialysis. What emergency dialysis effectively does is actually remove and purify the blood from Pradaxa. Basically, it manually removes the Pradaxa from a patient’s system.
This type of procedure however is unlikely in the event of a serious bleeding incident. Emergency room doctors would likely be unable to perform emergency dialysis for a patient while trying to address a Pradaxa internal bleeding trauma. So, for all intents and purposes, there is no Pradaxa reversal agent.
If you or a loved one have taken Pradaxa and has suffered from a traumatic bleeding event which has either led to an extended hospitalization or death, you may be entitled to financial compensation through a Pradaxa Lawsuit. Currently, Pradaxa Lawsuits around the country are being gathered on behalf of those wronged by the makers of Pradaxa. There is no known Pradaxa reversal agent, and the makers of Pradaxa failed to warn patients of that fact for more than a year after Pradaxa’s introduction. Please speak with an expert Pradaxa Lawyer at our firm today to discuss your options for a Pradaxa lawsuit.