FDA: Statement on the Impact of Recalled Monitoring Device on Rivaroxaban Study

The ROCKET-AF study provided the primary data to support the 2011 approval of Xarelto.

After further investigation into the faulty monitoring device used in the ROCKET-AF clinical trial, the Food and Drug Administration (FDA) has concluded that the trial results were not affected by the device and that rivaroxaban (Xarelto; Janssen) continues to be a safe and effective alternative to warfarin in patients with atrial fibrillation.

The ROCKET-AF study provided the primary data to support the 2011 approval of Xarelto, however in July 2016, the device used to monitor warfarin therapy in the control group, the Alere INratio device, was recalled due to the potential to generate inaccurate results. The rationale for the recall raised the possibility that patients in the warfarin group were over-anticoagulated as a result of use of the device, possibly distorting the results of the study by increasing the rate of bleeding in the warfarin arm.

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Upon learning of the recall, Janssen and the FDA conducted a variety of analyses to find out the impact the device had on the safety and efficacy of the trial. After analyzing the data, the FDA concluded that no changes to the rivaroxaban labeling are warranted as the effects on strokes or bleeding, including bleeding in the head, were minimal.

Xarelto is a factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also indicated for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, as well as for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

For more information visit FDA.gov.