Xarelto (Rivaroxaban) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013
- Premature discontinuation of Xarelto increases the risk of thrombotic events, and spinal/epidural hematoma…
WARNINGS AND PRECAUTIONS
- Increased Risk of Thrombotic Events after Premature Discontinuation - Premature discontinuation of any oral anticoagulant, including Xarelto, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events…
- Patients with Prosthetic Heart Valves - The safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves. Therefore, use of Xarelto is not recommended in these patients.