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The dangers of using Pradaxa were exposed quickly to the American public after hundreds of adverse events were reported to the FDA in its first year of use. In fact, Pradaxa has been linked to more adverse effects and deaths than any other anticoagulant since its release in 2010. Reports of death from the use of Pradaxa have been more than seven times higher than similar reports for any other blood thinner. The Food and Drug Administration (FDA) even started a formal safety review of Pradaxa barely a year after initial approval.
Pradaxa has been shown to be dangerous drug for patients, especially the elderly, because it lacks a reversal agent, or antidote. This means that if a patient’s blood should become overly thinned, there is no way to reverse it and bleeding becomes uncontrolled and often deadly. Since most patients using Pradaxa are older, the lack of a reversal agent or method of reversal aside from hospital-initiated dialysis is extremely dangerous. Most sick or elderly people cannot withstand the harsh administration of dialysis to remove the drug from their blood system.
The risk of Pradaxa bleeding is highest in people age 75 and over, with kidney problems, and/or with recent or recurrent intestinal bleeding due to a stomach ulcer. Patients taking other medications such as anticoagulants, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) are also at risk for a major adverse bleeding event.pr
Recent reviews of Pradaxa’s clinical trials show that its manufacturer failed to reveal the known increased risk of bleeding for elderly patients when compared to warfarin. Other study irregularities and concerns are now being revealed to the public on an ongoing basis.
Worse yet, Pradaxa’s German manufacturer, Boehringer Ingelheim, used misleading marketing tactics to increase sales and did not adequately warn physicians or patients about the risks associated with Pradaxa. Drug marketing touted the lack of a need for medical monitoring of those taking Pradaxa, when in reality the lack of an ability to test the levels of Pradaxa in the bloodstream is one of the reasons why this drug is so dangerous. These factors have led to hundreds of deaths throughout the United States and around the world.
Raizner Slania has the knowledge and experience to handle injury claims arising from pharmaceutical drug use. Our attorneys will take the time to evaluate your claim to find the best approach to help you recover for your loss. Please contact us today to find out more information about Pradaxa lawsuits.