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Off-Label Use of Pradaxa on the Rise

Filed October 11th, 2012 Laurie

A new study found that oral anti-coagulation therapy among atrial fibrillation patients has changed little since the 2010 introduction of Pradaxa as a treatment to prevent stroke in that population. Additionally, researchers at the Johns Hopkins Bloomberg School of Public Health found that the use of Pradaxa as a treatment for deep vein thrombosis and other off-label purposes has increased.

In October 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa to prevent blood clots and strokes in patients suffering from atrial fibrillation, the most common form of irregular heartbeat. The new study utilized data from the IMS National Disease and Therapeutic Index to quantify pharmacy expenditures for Pradaxa and warfarin from 2007 through 2011. Results show that even though doctors have been rapidly adopting Pradaxa as therapy, most patients with atrial fibrillation still aren’t receiving any anti-coagulant therapy at all.

Pradaxa was thought to be a significantly safer and more effective alternative to warfarin, a blood thinner also known as Coumadin. Both warfarin and Pradaxa can cause serious internal bleeding, and there is no antidote for Pradaxa. In their latest QuarterWatch Report, the Institute for Safe Medication Practices (ISMP) said that Pradaxa “accounted for so many reports of serious adverse drug events that was prominent in several different categories.”

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