November 9, 2012 — According to a U.S. Food and Drug Administration (FDA) review of Pradaxa bleeding incidents, the risk of serious bleeding among new users of Pradaxa is equal to new users of warfarin, which has been used since the 1950s. However, some critics have pounced on the study, calling it “flawed,” because it does not address the fact that Pradaxa lacks an emergency reversal agent, while warfarin can be reversed with Vitamin K.
The study also did not compare the outcome of patients who start bleeding on Pradaxa or warfarin. For example, even if the drugs have a comparable risk of bleeding, one drug could be associated with more injuries and deaths.
Pradaxa’s lack of an effective reversal agent can make the difference between life and death in an emergency. Since Pradaxa was released on the U.S. market in 2010, emergency room doctors have struggled to treat bleeding in Pradaxa patients. So long as Pradaxa is in a patient’s body, it inhibits an enzyme that is necessary for clotting. During an emergency, blood clots are necessary to stop bleeding. The only way to inactivate Pradaxa is with several hours of dialysis. Doctors in trauma centers around the country have found that traditional treatments involving blood plasma transfusions have been ineffective to stop bleeding in Pradaxa patients, which may increase their risk of severe injury or death.
Despite the risk, Pradaxa is gaining a larger share of the blood-thinning market. According to a New York Times article from November 2012 titled A Promising Drug With a Flaw, “By the end of 2011, after just over a year on the market, 17% of patients were being prescribed Pradaxa, compared with 44% for warfarin.”
As more and more people start using Pradaxa, the number of deaths and injuries has skyrocketed. According to the Institute for Safe Medicine Practices (ISMP), Pradaxa was associated with 542 patient deaths and more side effects than any other drug in 2011, all while generating sales of more than $1 billion.
Many people who were injured are now seeking justice by filing a lawsuit. There are currently 138 lawsuits involving 151 plaintiffs in the Pradaxa Multidistrict Litigation (MDL) located in the U.S. District Court for the Southern District of Illinois, were Judge David Herndon presides.
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