Boehringer Ingelheim s new anticoagulant drug Pradaxa was approved yesterday by the FDA to prevent blood clots in patients with atrial fibrillation. Compared to warfarin, an anticoagulant medication that has been in use since the 1950s, Pradaxa does not require frequent monitoring with blood tests. Further, it was more effective at preventing strokes the result of clots being embolized to the brain than the older drug in clinical trials.
Medically, this is very important, says ACSH's Dr. Gilbert Ross. Pradaxa will be used for the same indications and for the same patient populations as warfarin, which are those patients who experience atrial fibrillation an irregular beating of the heart that is associated with a high risk of blood clot formation, which may lead to stroke or a pulmonary embolism.
Even though Pradaxa seems more effective and easier to use, it is still associated with some adverse side effects, including bleeding, gastrointestinal symptoms, stomach pain, nausea, heartburn and bloating.