New Indication for Xarelto
October 27, 2017 – The U.S. FDA has approved a new indication for Xarelto® (rivaroxaban), manufactured by Janssen Pharmaceuticals. In its 10mg tablet form, Xarelto is now indicated for use to decrease the risk of repeated venous thromboembolism (VTE) in patients who have been taking anticoagulants for at least six months. Recommended dosing is once per day.
A factor Xa inhibiting anticoagulant, Xarelto already holds a number of other indications, including: treatment of deep vein thrombosis (DVT); treatment of pulmonary embolism (PE); and reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Additional 15mg and 20mg forms are available for these indications.
Xarelto carries a black box warning indicating that patients should not stop the medication prior to the end date recommended by their doctor, as this may heighten their risk for thrombotic events (caused by the formation of a blood clot inside of a blood vessel) such as strokes. In addition, it carries a black box warning that cautions against the risk of spinal/epidural hematomas that can lead to paralysis when undergoing spinal procedures while on Xarelto. Like all anticoagulant drugs, Xarelto may increase the risk of excessive, potentially fatal bleeding.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.