February 1, 2013 — In the most recent QuarterWatch report from the Institute for Safe Medicine Practices (ISMP), the blood-thinning medication Pradaxa (dabigatran) has been linked to a 5-fold increased risk of bleeding deaths than Coumadin (warfarin) — 14% of Pradaxa users died after suffering a hemorrhaging bleed, compared to 4% of warfarin users. The report was based on adverse event data that was voluntarily submitted to the U.S. Food and Drug Administration (FDA) MedWatch system in the last quarter of 2012.
The investigation of MedWatch reports also linked Xarelto (rivaroxaban), which is another blood-thinning medication, to an increased risk of blood clots in patients who underwent hip or knee replacement surgery and were given the 10-mg dose. Xarelto is supposed to reduce the risk of blood clots, which raises potential concerns about the drug’s “suboptimal” effectiveness at the 10-mg dose for this patient group.
The ISMP researchers also raised concerns about the goal of creating single-dose blood-thinning medications, as opposed to warfarin, which requires frequent blood tests to adjust multiple daily doses. The ISMP researchers wrote:
“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.”
When the ISMP submitted their data to Boehringer Ingelheim, the company asserted that the 5-fold increased risk of death was not accurate. They cited a recent retrospective study of Pradaxa’s clinical trials, which found that patients who suffered major bleeding while taking Pradaxa “were no more severe and consumed no more medical resources than warfarin bleeds,” according to the QuarterWatch report.
Many Pradaxa lawsuits have been filed by individuals who suffered major bleeding after using the drug. Bleeding is a very common side effect of blood-thinning medications, but Pradaxa and Xarelto have no reversal agent — unlike warfarin, which can be reversed with a dose of Vitamin K. When a Pradaxa patient is in an accident, the only way to inactivate Pradaxa and stop the bleeding may be with several hours of dialysis.
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