FDA review confirms rivaroxaban’s safety, efficacy in patients with atrial fibrillation

After a thorough review, the FDA has concluded that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin in patients with atrial fibrillation.

The FDA’s Oct. 11 announcement came three months after Alere voluntarily recalled its INRatio and INRatio 2 devices, which were used to monitor warfarin in the ROCKET-AF trial. Results of that study, which compared warfarin and rivaroxaban, supported the FDA approval of rivaroxaban in 2011.

When Alere acknowledged that the INRatio devices could lead to inaccurate results, the FDA performed several analyses to determine if the devices affected the findings of the ROCKET-AF study. The FDA said in a news release that “effects on strokes or bleeding, including bleeding in the head, were minimal.”

The FDA has approved rivaroxaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The agency said no labeling changes would be needed due to issues with the INRatio devices.