The U.S. Food and Drug Administration (FDA) approved the new 10 mg dosing for Xarelto to reduce the risk of venous thromboembolism (VTE), according to an announcement from Janssen Pharmaceuticals.
The approval follows the FDA’s Priority Review and is based on data from EINSTEIN CHOICE, the only clinical study to conclude that Xarelto demonstrates superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates comparable to aspirin. VTE is the third most common cause of cardiovascular death worldwide, following heart attack and stroke.
The Xarelto prescribing information will now provide instructions for physicians to begin treatment with Xarelto 15 mg twice daily for the first 21 days after a VTE event. On day 22 through at least day 180, the daily Xarelto dose drops to 20 mg once a day. After a minimum of 180 days, physicians may prescribe Xarelto 10 mg once daily for patients who are at continued risk for deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
What is Xarelto?
Xarelto is a blood thinner prescribed to patients suffering from atrial fibrillation (irregular heart beat) who are at increased risk of formed a blood clot in the heart, which can travel to the brain and cause a stroke. Although all anticoagulants increase the risk of uncontrollable bleeding, Xarelto use has been connected to a greater number of bleeding issues, largely because there is no approved antidote available for patients who use the medication, and many of the side effects have been serious because the bleeding cannot be controlled.
Since approval in 2011, Xarelto has receive two black box warnings from the FDA:
- August 2013 – A black box warning stated that the discontinuation of Xarelto too soon could increase the risk of thrombotic events and spinal/epidural hematoma.
- March 2014 – A black box warning indicated that the ideal timing between the administration of Xarelto and neuraxial procedures in each individual patient is could not be determined.
Xarelto use has been linked to at least 370 deaths, according to a 2017 Chicago Tribune report.