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Research Reveals the High Risks of Pradaxa

New research into the popular blood thinners dabigatran (brand name Pradaxa) and warfarin (brand name Coumadin) indicate that the risks associated with dabigatran – Pradaxa internal bleeding, hemorrhaging, and even death from Pradaxa – are greater than those linked to warfarin. This information will likely be helpful to those patients who have already decided to file a Pradaxa lawsuit, the first of was recorded in March 2012.

Pradaxa internal bleeding a serious concern

Pradaxa, which was initially approved as a blood thinner in October 2010, was marketed as a more convenient treatment than warfarin, which requires regular blood tests to check dosage. However, the ease of Pradaxa was soon eclipsed by its potential risks; in the first quarter of 2011, the Food and Drug Administration (FDA) received over 500 reports of severe hemorrhages, including some resulting in death from Pradaxa. In December 2011, the FDA announced that it would be investigating Pradaxa internal bleeding and fatal events associated with the drug.

Study reveals 11.5% of patients experience Pradaxa side effects

Dr. Mark Wurster, M.D., Standing Stone Chief Medical Officer, conducted a study, “Dabigatran in the Real World,” comparing to Pradaxa and Coumadin; he submitted his results at the Thrombosis & Hemostasis Summit of North America (THSNA), held in May 2012 in Chicago. Over the course of one year, Dr. Wurster tracked 113 patients, each of whom switched from warfarin to dabigatran (Pradaxa). During the warfarin phase of the study, only one patient was hospitalized with warfarin toxicity; during the Pradaxa phase, Dr. Wurster observed one death from Pradaxa, four hemorrhaging episodes, one count of deep venous thrombosis, and one occurrence of atrial thrombus. Statistically speaking, only 0.88% of warfarin patients experienced complications, while 11.5% fell victim to Pradaxa side effects. The most affected were women and older patients.

Over 459 counts of death from Pradaxa reported in three-month period

Notably, there is no readily available antidote to Pradaxa bleeding, making the drug even more dangerous. Unfortunately, this danger has played out in the number of adverse event reports to the FDA: in the last quarter of 2011, the agency received 3,000 reports of side effects, including 459 counts of Pradaxa death – earning it the #5 spot on the FDA’s “Top Ten Drugs with the Most Adverse Reports” list for the fourth quarter of 2011. In practical terms, this risk will likely translate to more injuries and, therefore, more patients interested in filing a Pradaxa lawsuit to seek damages for their pain and suffering.

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