February 1, 2013 — According to a new report based on adverse events submitted to the U.S. Food and Drug Administration (FDA), the blood-thinning medication Pradaxa (dabigatran) is associated with a 5-fold increased risk of death compared to Coumadin (warfarin). About 19% of Pradaxa bleeding events resulted in death, compared to 4% of warfarin bleeding events. The findings were published by the Institute for Safe Medicine Practices (ISMP) in their QuarterWatch publication, which analyzes MedWatch reports submitted to the FDA Adverse Event Reporting System.
The report also found that Xarelto (rivaroxaban), another blood-thinning medication, was associated with a higher risk of blood clots in patients who received the 10-mg dose after hip or knee replacement surgery. Because blood-thinning medications are supposed to reduce the risk of blood clots, the ISMP raised concerns about whether the 10-mg dose is “suboptimal.”
The researchers also raised some serious concerns regarding the new blood-thinners. Although recent clinical trials have attempted to prove that Pradaxa and Xarelto are equally effective as warfarin but easier to use, ISMP researchers argued:
“The primary focus should be how to achieve safer use, not to make this risky treatment easier to use. … [Pradaxa and Xarelto] may have additional risks not fully understood, even if their overall safety profiles are comparable.”
Officials at Boehringer Ingelheim argued that the 5-fold increased risk of death was inaccurate. The company has recently conducted a retrospective study of their own clinical trials, and they have found that Pradaxa bleeding events “were no more severe and consumed no more medical resources than warfarin bleeds,” according to the ISMP.
However, the growing concern regarding Pradaxa and Xarelto is that unlike warfarin, which can be inactivated with a dose of Vitamin K, Pradaxa and Xarelto have no reversal agent. Pradaxa and Xarelto work by inhibiting an enzyme in a patient’s blood that is necessary for the formation of blood clots. In an emergency, patients must form blood clots to stop bleeding, and a blood-thinning medication must be inactivated. However, the only way to inactivate Pradaxa is with several hours of dialysis.
Do I have a Pradaxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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