Pradaxa Side Effects and Complications

Pradaxa (dabigatran etexilate) is a anticoagulant (blood thinner) that was approved by the FDA in October 2010, to prevent the formation and the lower the chances of blood clots in patients with atrial fibrillation. Atrial fibrilation (AF or AFib) is a condition in which the heart beats irregularly, which increases the chances of a person forming blood clots in the body and can lead to a possible stroke.

Pradaxa works by inhibiting the release of a key protein that is essential to the formation of blood clots.  It was touted by its manufacturer, Boehringer Ingelhim, as a safer alternative to traditional blood thinners like warfarin (Coumadin, Jantoven, Warfarin). Like all blood thinners, there is a chance that a person may hemorrhage and experience internal bleeding.  Unlike traditional blood thinners, though, Pradaxa initially did not have an antidote to reverse these effects.  If a person is taking a traditional blood thinner and starts to bleed internally, they can be given a Vitamin K shot to serve as a clotting agent.  No such treatment exists if a person is on Pradaxa. If a person continues to bleed internally, they may suffer severe injuries and can potentially die. Symptoms of internal bleeding include: lethargy, unusual bruising or bleeding, pink or brown urine, red or black tar-like stool, coughing up blood, vomiting blood, frequent nosebleeds, bleeding from the gums, etc. The FDA since announced its approval for Pradaxa to contain an antidote to reverse these potentially deadly side effects.