Pradaxa is a medication used to prevent stroke and blood clots in patients with atrial fibrillation. It has been widely prescribed since it’s release in 2010. Unfortunately, studies in the New England Journal of Medicine have warned that the lack of an effective treatment for severe bleeding caused by Pradaxa may put patients at risk. Unlike Warfarin (generic for Coumadin), patients who use Pradaxa cannot be given a reversal agent to halt the anticoagulant effects of the drug and stop severe bleeding. In December of 2011, the Food and Drug Administration launched an investigation into the side effects of Pradaxa after dozens of patients experienced extensive bleeding.
In the past two years, more and more patients have demonstrated complications with the drug, often leading to serious internal bleeding or death. Certain patients are at a higher risk for bleeding, such as patients age 75 or older, patients with pre-existing kidney problems, current stomach or intestinal bleeding due to ulcers or patients who are underweight. The drug has also been associated with a higher risk of heart attacks and chest pains. Critics of the Food and Drug Administration question why this dangerous drug had not been recalled. In 2011, a limited recall of Pradaxa was conducted as some lots were improperly labeled, but the drug itself is still being prescribed to patients. By the middle of 2012, more than 3.7 million patients in the U.S. alone filled Pradaxa prescriptions. Thousands of lawsuits are expected and will be consolidated to a special federal court in Illinois.
In 2012, the FDA determined Pradaxa did not pose an excessive risk of bleeding, however failed to address the potential for uncontrollable bleeding and the inability to reverse it. Instead, the FDA warned clinicians not to prescribe Pradaxa to mechanical heart valve patients. In 2013, the manufacturer added a black box warning cautioning that discontinuing the drug could raise the risk of a stroke in patients with atrial fibrillation and recommended use of another anticoagulant if the drug was discontinued. The black box warning also detailed a connection between Pradaxa and low blood platelet counts.
If you have suffered kidney failure, stroke, or other side effects of Pradaxa, contact a mass torts lawyer knowledgeable in these types of claims.