The Food and Drug Administration began an investigation of the anticoagulant drug Pradaxa in December 2011 after receiving dozens of reports of excess bleeding or death among patients who were taking the drug. Patients taking Pradaxa may face an increased risk of severe bleeding compared to users of similar drugs, according to the FDA’s investigation. The manufacturer of Pradaxa reports that at least 260 deaths have been linked to excessive bleeding among patients who were being treated with the drug.
Pradaxa was approved by the FDA in October 2010 as a blood thinning drug to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Unlike warfarin (Coumadin)—another anticoagulant drug—treatment with Pradaxa does not require frequent blood tests or carry the same risk of interaction with some foods and other drugs.
However, because of the way Pradaxa works to prevent the formation of blood clots, there is no reversal agent or antidote that can be used to treat patients who develop excess bleeding from the drug. According to a study published in the New England Journal of Medicine, the lack of an effective reversal agent creates a significant risk of Pradaxa side effects in patients who are being treated with this medication.
Pradaxa users who develop serious bleeding or other complications after taking the drug may require multiple blood transfusions, hemodialysis or other serious forms of treatment. Patients who suffered excess bleeding or other complications may be eligible to file a Pradaxa lawsuit regarding the injuries caused by the drug.
If you or a loved one have experienced serious bleeding or other side effects after taking Pradaxa, you may be eligible to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free consultation form located on this page.