November 4th, 2011
FDA Approves Rivaroxaban for Stroke Prevention in AF
Larry Husten, PHD
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.
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