Risk for Thrombotic Events Prompts FDA to Issue REMS for Rivaroxaban

The FDA has called for a risk evaluation and mitigation strategy, or REMS, for the oral anticoagulant drug rivaroxaban, which is marketed as Xarelto.

In a letter to health care professionals (2-page PDF; About PDFs) from Janssen Pharmaceuticals Inc., which markets Xarelto in the United States, Paul Chang, M.D., vice president of medical affairs, said that the FDA asked the company to produce both a patient medication guide and a communication plan to ensure prescribers are aware of important safety information regarding rivaroxaban to "ensure that the benefits of the drug outweigh the potential risks in patients with nonvalvular atrial fibrillation."

Those risks include an increased risk of thrombotic events, including stroke, if the drug is discontinued without introducing an adequate alternative anticoagulant, as well as a potential decreased efficacy of the 15 mg and 20 mg tablets if the drug is not taken with an evening meal.

The patient medication guide stresses the importance of talking with a physician before making any changes to the drug regimen.

The drug was approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in November. The drug also is indicated for prophylaxis of deep vein thrombosis, which can lead to pulmonary embolism, in people who undergo knee or hip replacement surgery.

Adverse events associated with use of rivaroxaban may be reported to Janssen Pharmaceuticals Inc. by calling (800) 526-7736, as well as to MedWatch, the FDA's Safety Information and Adverse Event Reporting System, by calling (800) FDA-1088 [332-1088] or via the MedWatch website.