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Despite Risks, Increasing “Off-Label” Use of Pradaxa

Despite Risks, Increasing “Off-Label” Use of Pradaxa

September 6, 2012 — Since the U.S. Food and Drug Administration (FDA) approved the blood-thinning medication Pradaxa (dabigatran) in 2010, the “off-label” use of this medication has increased dramatically. The FDA has only approved Pradaxa to reduce the risk of strokes in people with atrial fibrillation, a type of irregular heartbeat that can cause blood to pool in the heart and form blood clots, which can then cause strokes. However, Pradaxa is increasingly being prescribed to treat people with venous thromboembolism (VTE), hypertensive heart disease, and coronary artery disease — conditions the FDA has never approved.

Doctors are allowed to prescribe medications “off-label” (for uses not approved by the FDA), but there can be risks. Pradaxa has already been associated with a risk of severe bleeding — a side effect that is common among blood-thinning medications. However, one risk that is unique to Pradaxa is the fact that its blood-thinning effects cannot be easily reversed during a bleeding emergency. A patient using Pradaxa requires 2-3 hours of dialysis to reverse the anti-clotting effects of the drug. Patients taking Coumadin (warfarin), which is still the most popular blood-thinning medication in the U.S., can have the anti-clotting effects reversed with a simple dose of Vitamin K.

According to a study published in the journal Circulation, the proportion of people who received Pradaxa for atrial fibrillation dropped from 92% to 63% between the end of 2010 until the end of 2011. This drop reflects an increasing proportion of people who are being prescribed Pradaxa to treat something other than atrial fibrillation.

The researchers also found that one in four patients who were prescribed an anti-clotting drug were given Pradaxa. However, although the use of Pradaxa is increasing, researchers found that the rate of people given no anti-clotting medications has remained constant — about 35%.

The study was conducted by Dr. Caleb Alexander of Johns Hopkins Bloomberg School of Public Health in Baltimore. The conclusions of the study were drawn from data from the IMS Health National Disease and Therapeutic Index.

Since 2011, sales of Pradaxa have increased dramatically, and sales of warfarin have declined. Expenditures for warfarin dropped from $169 million per quarter in 2007 to $144 million in the last quarter of 2011. Expenditures for Pradaxa increased from $16 million in the fourth quarter of 2010 to $166 million in the last quarter of 2011.

Boehringer Ingelheim, the manufacturer of Pradaxa, is currently facing at least 72 lawsuits in a Multidistrict Litigation (MDL) located in the U.S. District Court for Southern Illinois. Many of these Pradaxa lawsuits allege that the drug company failed to adequately warn doctors or the public about the life-threatening risks of Pradaxa — including bleeding that cannot easily be reversed during an emergency.

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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