The Food and Drug Administration Mini-Sentinal Shows Rivaroxaban Is Associated with a Lower Risk of Ischemic Stroke Vs. Warfarin


Rivaroxaban (Janssen Pharmaceuticals) is an antithrombotic medication that inhibits clotting Factor Xa. It is available in oral tablet formulation for patients at risk of, or being treated for, deep vein thrombosis (DVT) and pulmonary embolism (PE) or to help prevent stroke and blood clots in patients with atrial fibrillation without heart valve disease. Rivaroxaban may reduce the risk of DVT, which can lead to PE in people who are having hip replacement or knee replacement surgery. 

The Food and Drug Administration (FDA) Mini-Sentinel assessment confirmed safety and efficacy of rivaroxaban in a phase 3 clinical trial, the results of which were published in Pharmacoepidemiology & Drug Safety. The findings are consistent with other analyses. Of note, the FDA Mini-Sentinel report showed a lower risk of ischemic stroke with rivaroxaban compared to warfarin throughout the more than three-year analysis. 

The Mini-Sentinal is a working pilot project to develop active safety surveillance of approved FDA-regulated medical products. It is part of a national electronic system for such monitoring and uses existing electronic healthcare data from multiple sources. 

“We’re pleased to see the Sentinel Initiative in action and that the FDA’s findings are consistent with results from other independent real-world and post-marketing studies,” said Paul Burton, MD, PhD, FACC, Vice-President, Medical Affairs, Janssen Pharmacticals, Inc.


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