Pradaxa History

Approximately one percent of the total population is affected by atrial fibrillation worldwide, or approximately 70+ million people in the world, and more than 2 million people in the United States alone have this condition. Atrial fibrillation is a disease that typically has an impact on aging populations, and indeed, its prevalence increases with age.

While some cases of atrial fibrillation have no apparent or known cause, various conditions and/or lifestyle factors are believed to trigger or increase the odds of developing the condition. For example, the following are believed to trigger atrial fibrillation in adults: high blood pressure; being obese or overweight; diabetes; having an overactive thyroid gland; lung cancer; and drinking too much alcohol or binge drinking.

Historically, atrial fibrillation has been treated with the prescription drug warfarin. Warfarin blocks the formation of tiny fibrin threads that help hold together the platelets that collect in a patient’s blood to form a blood clot. Like all blood thinners, warfarin can cause unexpected bleeds. Warfarin also has two other noteworthy limitations: (1) it requires blood tests every 1 to 4 weeks to establish a patient’s optimal level of anticoagulation, and (2) it interacts negatively with scores of other drugs. In spite of these apparent limitations, however, warfarin also has an important benefit; if an unexpected bleed occurs, it can be reversed by administration of vitamin K into the bloodstream.

Pradaxa gained FDA approval in October of 2010 and is the first new treatment alternative to warfarin in nearly 60 years. It quickly gained favor with patients over warfarin as it does not require monthly blood testing due to Pradaxa’s “one size fits all” dosing of 150mg. In practice, however, this means that doctors are not monitoring a patient’s blood level to see if they are getting too much of Pradaxa’s active ingredient.