Changes to Xarelto’s Label are Not Enough

Oct 15, 2018
  • Despite facing multiple lawsuits over patient’s experiences with heavy and sometimes fatal bleeding problems, Xarelto’s label still lags behind in giving patients a sufficient safety warning regarding the use of the medication.  The label was modified in June of 2018 to let medical providers know about a FDA approved agent called AndexXA which is intended to reverse the side effects of Xarelto. AndexXa was cleared for use in May of 2018, and is the first of its type to help reduce the effects of taking Xarelto. This is a critical step in helping those patients who suffer from significant internal bleeding as a result of using Xarelto.

    Even though these changes have been implemented, essential information about the severity of the risk of prescribing Xarelto is still being overlooked. For example, the label does not mention that using both Xarelto and aspirin together can cause a 93 percent increased chance of major bleeding, in comparison to just taking Xarelto by itself. Furthermore, due to the medication’s drastic fluctuation from patient to patient some individuals can have a higher concentration of the drug in their system allowing them to be at a higher danger for bleeding, versus another individual taking the same dosage. Even though testing has been made available to allow for monitoring the amount of the drug in a patients system, However the current U.S. label continues to claim that no such testing is available to measure the concentration of the drug. This claim directly disputes the label that is provided on the medication in Canada and Europe, which hinders U.S. physicians and puts their patients at a greater danger to having serious or fatal bleeding problems while taking the medication.

    If you or a loved one have experienced severe or fatal bleeding issues as a result of taking Xarelto, contact our office at 303-999-9999 or at 303-835-9342. You may also visit our practice area page on pharmaceutical drugs at for more information.