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FDA Warns Against Pradaxa Use In Patients With Mechanical Heart Valves


The U.S. Food and Drug Administration (FDA) recently issued a Drug Safety Communication warning consumers and healthcare providers that the anticoagulant Pradaxa should not be used in patients with mechanical heart valves. According to the FDA, a European clinical trial – called the RE-ALIGN trial – was prematurely terminated because Pradaxa patients were found to have a higher risk of stroke and heart attack, and were more likely to develop blood clots on the mechanical heart valves compared to patients taking the blood thinner warfarin. Researchers involved in the clinical trial also found a greater risk of bleeding after valve surgery in Pradaxa users than in warfarin users. If you took Pradaxa and have since suffered a serious side effect like heart attack or stroke, don’t hesitate to protect your legal rights. Contact our compassionate Pradaxa attorneys at Bandas Law Firm today for legal help.


Pradaxa (dabigatran) is a medication commonly used to reduce the risk of blood clots and strokes in patients with a medical condition called atrial fibrillation. Unfortunately, since the drug was introduced in 2010, the FDA has received reports of thousands of bleeding side effects and hundreds of deaths associated with the anticoagulant medication. In fact, Pradaxa warnings have indicated that the anticoagulant may actually lead to an increased risk of heart attack and stroke, the very conditions the drug is meant to prevent. Pradaxa may also be associated with complications like internal bleeding or hemorrhaging, heart disease and death. Pradaxa has not been approved for use in patients with atrial fibrillation caused by heart valve problems, and the FDA is now warning against the use of Pradaxa in patients with mechanical heart valves.


Although Pradaxa was touted by its manufacturer as a superior alternative to the well-established warfarin, the risk of side effects with Pradaxa use may well outweigh the medication’s benefits for some users. In addition to this latest setback for Boehringer Ingelheim, the German company also faces mounting lawsuits filed on behalf of patients who suffered uncontrollable bleeding while taking Pradaxa. In some cases, the bleeding side effects were fatal. If you have experienced a major complication that you believe to be associated with the blood thinner Pradaxa, contact our knowledgeable attorneys at Bandas Law Firm as soon as possible. Our law firm is located in Corpus Christi, and our lawyers have extensive experience protecting the rights of consumers harmed by pharmaceutical drugs. Contact our attorneys at Bandas Law Firm today to discuss your legal options.