November 4th, 2011

FDA Approves Rivaroxaban for Stroke Prevention in AF

The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the risks and adverse reactions associated with the drug.

The label does not provide firm guidance on the relative merits of rivaroxaban and warfarin in AF patients:

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.

Some panelists at the FDA advisory panel in September had suggested that rivaroxaban should only be used in patients unable to take warfarin.

Click here to download a PDF of the Xarelto label.

Click here to read the FDA announcement.

Click here to read the press release from Johnson & Johnson.

Comments are closed.