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Pradaxa is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation (AFib) not caused by a heart valve problem. It was designed as a safer alternative to warfarin (also known as Coumadin), which has been the staple blood thinner for over 60 years.
Both warfarin and Pradaxa have been shown to work well, but they can also cause excessive bleeding. However, in the case of Warfarin, there is an antidote to stop the bleeding, but for Pradaxa there’s not.
However, despite continuing safety concerns involving the risk of uncontrollable bleeding events, federal drug regulators have expanded the approved uses of the blood thinner Pradaxa to include the treatment of deep vein thrombosis and pulmonary embolism. Deep vein thrombosis and pulmonary embolism are the side effects of blood clots, and the third most common form of cardiovascular disease.
The approval only applies to patients “who have been treated with a parenteral anticoagulant for five to 10 days.” It is also approved to “reduce the risk of these blood clot disorders among patients who have been previously treated and in whom the conditions may recur.”
History of Pradaxa Bleeding Concerns
Created by Boehringer Ingelheim, Pradaxa (dabigatran) is an anticoagulant drug that was introduced in 2010 for stroke prevention. The medication was the first of a new class of drugs promoted as superior alternatives to warfarin, because they were supposedly easier to use and require less monitoring.
Shortly after approval, Pradaxa began to rack up a record number of adverse event reports submitted by doctors and patients, often involving incidents of uncontrolled bleeding or hemorrhages linked to Pradaxa side effects. In fact, the number of reported bleeding events has made Pradaxa one of the most frequently cited drugs in adverse event reports submitted to the U.S. Food & Drug Administration.
At the moment there are more than 2,000 Pradaxa product liability lawsuits pending in federal court. Every Pradaxa lawsuit is similar, alleging Pradaxa side effects caused severe bleeding issues that sometimes turned fatal. While warfarin-caused bleeding events can be given vitamin K to stop the drug’s effects, until Pradaxa has an approved antidote, the number of Pradaxa complications will continue to climb.
As part of a multidistrict litigation (MDL) or mass tort, all Pradaxa bleeding lawsuits filed in federal courts have been centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois for coordinated handling. The first Pradaxa bleeding trials are expected to begin later this year, with a series of four bellwether cases set to begin between September 2014 and March 2015.
Join a Free Pradaxa Class Action Lawsuit Investigation
If you or a loved one were medically diagnosed with internal bleeding problems after using Pradaxa, you may be able to take legal action against the drug’s manufacturer. Joining a Pradaxa class action lawsuit or filing an individual Pradaxa lawsuit may help you recover compensation for medical bills, pain and suffering, and other damages. Obtain a free case evaluation now:
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