Pradaxa is an anti-coagulant (or blood thinner) intended to reduce the risk of stroke and blood clots in patients suffering from atrial fibrillation (AFib). AFib is a condition in which the heart beats irregularly, increasing the chance of blood clots and stroke. Pradaxa is also prescribed for treatment of deep vein thrombosis (DVT), which is a medical term that refers to a blood clot in a vein, often in the legs, and pulmonary embolism (PE), a blood clot in the lungs.
Pradaxa is one of several drugs recently developed as alternatives to Warfarin (also known as Coumadin), a different type of blood thinner that has been on the market since 1954. The effects of Warfarin can be rapidly reversed with a single dose of vitamin K. Pradaxa, on the other hand, was approved by the U.S. Food and Drug Administration (“FDA”) without an accompanying antidote.
Pradaxa is known to cause severe bleeding events that may lead to disabling, life-threatening or even fatal outcomes including heart attack and stroke. Additionally, although it is intended to prevent blood clots, Pradaxa may actually cause a particularly dangerous type of blood clot in the spinal cord in patients who have undergone a spinal tap or received spinal anesthesia. Patients who undergo these procedures while on Pradaxa are at a higher risk of developing this type of clot if they also suffer from a genetic spinal defect, have a spinal catheter in place, have a history of spinal surgery or repeated spinal taps, or are also using other drugs that can affect blood clotting. This type of blood clot can lead to permanent paralysis.
Thousands of injured patients filed lawsuits against Boehringer Ingelheim, the German manufacturer of Pradaxa. Boehringer has already paid out $650 million to settle more than 4,000 of these lawsuits. During the course of litigation, documents surfaced showing Boehringer hid a study from the FDA that found 19.5 out of every 10,000 Pradaxa patients would suffer uncontrollable bleeding. Boehringer did not submit the results of this study when it sought FDA approval of Pradaxa. Instead Boehringer submitted results from a different study that found a risk of only 6.1 out of 10,000. A later independent study, published in the Journal of the American Medical Association, found that Pradaxa increased bleeding risks by up to 60% over Warfarin.
If you or a loved one has taken Pradaxa and experienced any adverse side effects, you may be entitled to compensation. The attorneys at Canepa, Riedy, Abele, & Fischer are currently offering free case evaluations to patients who have been harmed by Pradaxa. To learn more about your legal options, please contact us for a free consultation.