Rivaroxaban (brand name Xarelto) approved for stroke prevention in non-valvular atrial fibrillation

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Tuesday, April 16, 2024

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Pick a Topic: Home New Postings Patient Postings Clinician Postings Join Our Email List Useful Web Links CE Opportunities Training Programs Guidelines DVT & PE Stories Editorial Board Financial Support About ClotCare DVT Coalition Contact Us Find info on a: Specific Medicine or Treatment Type of Medicine or Treatment Condition or Medical Procedure Lab Test Procedure Management Issue ClotCare complies with the HONcode standard for trustworthy health information: verify here. ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March.	Rivaroxaban approved for stroke prevention in non-valvular atrial fibrillation Henry I. Bussey, Pharm.D. November, 2011 Rivaroxaban (brand name Xarelto), an oral anti-factor Xa (FXa) inhibitor, was approved on Nov. 4, 2011 for stroke prevention in individuals with non-valvular atrial fibrillation. The FDA report (http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm278646.htm) indicates that the product information will contain a boxed warning advising individuals taking the drug to consult their health care professional before discontinuing the drug because of an increased risk of stroke following discontinuation of the drug. According to CardioSource, the FDA's Cardiovascular and Renal Drugs Advisory Committee recommended that rivaroxaban should only be offered as a third-line therapy (behind warfarin and dabigatran); but such a limitation was not addressed in the FDA approval announcement. In the ROCKET AF (atrial fibrillation) trial with rivaroxaban vs warfarin, there was no "signal" of an increased risk of myocardial infarction with rivaroxaban as was seen with dabigatran in the RE LY trial (and discussed on ClotCare at clotcare.org/dabigatran_vs_warfarin.aspx). In addition, the issue of 30-day or 60-day product stability with dabigatran (also discussed on ClotCare at clotcare.org/dabigatran_special_handling.aspx) has not been an identified problem with rivaroxaban. It would seem, therefore, that choosing between either of the new agents (rivaroxaban or dabigatran) involves weighing product-specific limitations for each agent.	Have questions? Ask ClotCare. Send questions by email to webmaster@clotcare.org. ClotCare is a 501(c)(3) non-profit organization generously supported by your tax-deductible donations and grants from our industry supporters. New Postings: Click here to view full list of new postings
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