"Pradaxa is a novel, new blood-thinning agent," Malik says. "It was designed to replace Coumadin, which is a drug that was around for many years, and it was indicated for the prevention of blood clots."
The issue with blood thinners is that they can cause bleeding incidents, in which the patient receiving the blood thinner bleeds uncontrollably, because his blood is not able to clot. According to Malik, where Pradaxa is different from other blood thinners is that there is no way to stop the bleeding once it has started.
"The biggest problem with Pradaxa is the tendency for patients to bleed as a side effect," Malik says. "This is especially a problem we see in older people and in those with pre-existing kidney disease. There is no antidote, unlike with Coumadin where the patient could be given vitamin K to stop the bleeding. The only therapy for patients on Pradaxa who start bleeding is dialysis, but that would take time to instigate and set up."
There have been reports of patients suffering severe injury, and in some cases dying, after injuries resulted in what appeared to be relatively minor bleeding. That minor bleeding, because it was not stoppable, became a major health problem. Among the injuries linked to the use of Pradaxa are cerebral hemorrhage, stomach bleeds, kidney bleeds and heart attack. Some patients have died from unstoppable internal bleeding, according to Malik.
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Lawsuits have now been filed against the maker of Pradaxa, alleging the drug is linked to serious health risks.
"The cases are in multi-district litigation in the Southern District in Illinois under Judge Herndon," Malik says. "There are more than a dozen lawsuits filed and the cases have been consolidated. There have not been any settlements to date. Patients who were hospitalized for several days with serious bleeding issues, including gastrointestinal bleeding, kidney bleeding, cerebral hemorrhage and stroke, should consider contacting an attorney."