Popular blood-thinner Xarelto (rivaroxaban) has been approved by the FDA to reduce the risk of venous thromboembolism (VTE). The 10mg once daily dosage is to be prescribed following six months of initial anticoagulation therapy, and is being touted in the medical community as the go-to blood thinner over aspirin.
Manufacturer Janssen Pharmaceuticals explained their use of the EINSTEIN CHOICE study, “a Phase 3, global, randomized, double-blind, superiority study that compared the efficacy and safety of two doses of XARELTO® (10 mg and 20 mg once daily) with aspirin 100 mg once daily for the management of VTE.”
The details of their press release stated they “evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy.”
“Patients taking either Xarelto dose had significantly fewer recurrent VTE compared to those taking aspirin. Specifically, Xarelto 10 mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20 mg by 66 percent.”
Xarelto was first approved by the FDA in 2011. Initially cleared to treat deep vein thrombosis after knee and hip replacement surgery, its use was broadened the following year to include treatment of blood clots, as well an increase in stroke prevention.
The FDA issued its first Black Box Warning for Xarelto in 2013, updating the adverse reactions in 2014. Spinal hematoma and thrombocytopenia, a platelet deficiency that causes bruising, bleeding into the tissue, and slow clotting, were the focuses of that safety warning update.
In 2016, the FDA released yet another communication alerting those with acute renal failure and end-stage renal disease that Xarelto can cause bleeding when taken with SSRI’s and other clot-prevention medication.