Potential Risks Of Using Pradaxa. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is recognizing Atrial Fibrillation Awareness Month by warning that Boehringer Ingelheim’s Pradaxa is allegedly associated with potentially fatal hemorrhages. According to the National Heart Lung and Blood Institute, AF is the most common form of cardiac arrhythmia, a condition where the heart beats at an abnormal rate.
A regular heartbeat is controlled by an electrical system that sends a signal from the top of the heart to the bottom. In patients with atrial fibrillation, the electrical signal begins in the wrong place and doesn’t travel normally throughout the heart. As a result, it can cause the upper chambers, or atria, to fibrillate; this means that the atria contract very quickly at an abnormal rhythm.
When this happens, the upper and lower chambers of the heart (ventricles) are no longer coordinated and the flow of blood is disrupted. AF patients are thus at an increased risk of blood clots and stroke because the blood can pool in the upper chambers of the atria.
In October 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa to prevent blood clots and stroke in patients who have atrial fibrillation. According to a recent report published in the Journal of the American Medical Association (JAMA), the FDA’s expedited approval of Pradaxa has potentially exposed the public to serious risks without adequate data to support its use.
The drug was launched as a replacement for warfarin
The drug was launched as a replacement for warfarin, an older anticoagulant that requires frequent monitoring and dietary restrictions. Although the drug was initially considered to be a beneficial innovation, the use of Pradaxa has since raised serious safety concerns.
Last fall, approximately 260 Pradaxa-related deaths were reported to the European Medicines Agency’s (EMA) database. The report drew attention on an international level, and shortly afterwards the FDA launched a safety review of the drug.
Pradaxa’s main drawback is its lack of an antidote. Unlike warfarin, there is no way to stop a hemorrhage in a patient who experiences bleeding due to the drug. This suggests that even minor events, such as a simple fall, could have fatal consequences. In March, the Journal of Neurosurgery addressed this issue by publishing a case report of a Pradaxa patient who died of a cerebral hemorrhage after a ground-level fall in his home.
In their latest QuarterWatch Report, the Institute for Safe Medication Practices (ISMP) said that Pradaxa “accounted for so many reports of serious adverse drug events that was prominent in several different categories”.
In addition to being cited in 542 patient deaths, Pradaxa was named in 2,367 cases of hemorrhage, 291 cases of acute kidney failure and 644 cases of stroke.
Parker Waichman LLP is offering free lawsuit consultations to victims of Pradaxa bleeding side effects. If you or a loved one took Pradaxa and experienced a life-threatening bleeding event, please contact their office by visiting the firm’s Pradaxa internal bleeding page at yourlawyer.com. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).