Weighing the Odds with Pradaxa

Stroke is the third leading cause of death in the U.S., taking the lives of about 140,000 people annually. Of those who survive, a stroke often has a significant impact on the quality of life of these people. It is no wonder that there should be great interest in finding effective medication to prevent strokes.

Warfarin was approved for use in the U.S. in 1954 as an oral coagulant, and continues to be widely used despite the concomitant health risks. These include intracranial bleeding and extracranial hemorrhaging. Warfarin also requires frequent doctor visits to monitor blood warfarin levels and a restricted diet. Until quite recently, warfarin led the race for the number of adverse event reports (AERs)and deaths caused by a drug in the Food and Drug Administration at 1,106 events which includes 72 fatalities in 2011.

That’s nothing compared to the newer and “safer” anticoagulant drug Pradaxa (dabigatran) from Boehringer Ingelheim. Introduced into the market in 2010, it didn’t take long for the stroke prevention medication to get a sizable share of it. However, Pradaxa racked up 3,781 AERs, which included 542 fatalities in 2011. In that year, there were more than 30 million users of warfarin in the U.S., and about 2.2 million users of Pradaxa. Comparatively speaking, Pradaxa is way out there when it comes to AERs.

Exactly how much safer Pradaxa is compared to the decades-old warfarin has become a source of speculation for many health experts. It is undeniable that Pradaxa is much easier to take than warfarin because there are fewer restrictions. But barely 3 years in the market and Pradaxa is already the star of multidistrict litigation (MDL) in the Southern District of Illinois.