FDA Approves Rivaroxaban for Blood Clots in Acutely Ill Medical Patients

To date, the FDA has granted rivaroxaban 8 indications, 6 of which are specifically for the treatment, prevention, and reduction in the risk of recurrence of venous thromboemolism across a wide range of patient populations.

Rivaroxaban (Xarelto, Janssen) has been approved by the FDA for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

Rivaroxaban can now be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. To date, the FDA has granted rivaroxaban 8 indications, 6 of which are specifically for the treatment, prevention, and reduction in the risk of recurrence of VTE across a wide range of patient populations. These indications are the most of any direct oral anticoagulant (DOAC).

Acute medical illness is a broad term used to describe serious, yet uncommon, medical conditions. These almost 7 million patients are at an increased risk of blood clots for up to 3 months after hospital discharge, with an 80% of events happening within the first 6 weeks.

In response to the burden of VTE in hospitalized patients, the Surgeon General issued a Call to Action in 2008 for key stakeholders to build a coordinated plan that could lead to a reduction in VTE across the United States. However, a recent study published in American Journal of Cardiology fond that in-hospital VTE rates continue to rise and more work is needed to reduce the burden of VTE especially among those at lower risk.²

Guidelines currently recommend that acutely ill medical patients at risk of VTE receive anticoagulants, typically injectable agents, in the hospital to protect them from blood clots, but advise against routine anticoagulant use after leaving the hospital. Research shows that many patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience.

Reference

U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients [press release]. PR Newswire website. Published October 14, 2019. https://www.prnewswire.com/news-releases/us-fda-approves-xarelto-rivaroxaban-to-help-prevent-blood-clots-in-acutely-ill-medical-patients-300937733.html. Accessed October 14, 2019.
Mehta KD et al. Trends of Inpatient Venous Thromboembolism in United States Before and After the Surgeon General's Call to Action. Am J Cardiol. 2019;124:960−965.