Oncoprescribe Blog: Is Warfarin on its way out?

November 17th, 2010

May be, but not quite. Warfarin is one of the most dangerous oral prescription drugs and is in the top 10 drugs with serious adverse events as has been reported by the  FDA’s Adverse Event Reporting System. The risk of bleeding complications with warfarin is as high as 10%-16%. ( www.archinternmed.com). For this reason FDA has mandated “black box” product warning of bleeding complication for warfarin, in October 2006. Further this drug requires frequent blood monitoring to ensure efficacy and safety. Interaction with other drugs and dietary products is a major drawback of warfarin. First approved for use in the early 1950’s,  warfarin is the most widely prescribed anticoagulant drug in the USA and has remained largely unchallenged until now.

The new players  on the stage are Dabigatran (Pradaxa) and Rivaroxaban (Xarelto). These agents are oral direct thrombin inhibitors. Unlike warfarin, laboratory monitoring is not necessary and drug interactions are uncommon with these agents. The FDA recently approved Dabigatran for stroke prevention in patients with atrial fibrillation. We will soon have these agents also available for the prevention and treatment of Deep Vein Thrombosis (DVT).  This is welcome news for patients on warfarin, who get  stuck at least once a month for laboratory monitoring and have to follow stringent dietary habits to reap the benefits of warfarin.