June 18, 2012 – Reports involving hundreds of patient deaths on Pradaxa (generic: dabigatran) have increased concerns about the controversial new blood thinner, according to a new report by Reuters. A growing number of U.S. heart doctors are alarmed at the high number of uncontrollable bleeding events associated with Pradaxa, as well as with Xarelto, another new drug in the same class.
Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
During 2011, the first full year Pradaxa was on the market in the United States, the drug was linked to more adverse event reports (AERS) submitted to the FDA than any other medication. Over the course of the year, Pradaxa was associated with:
- 3,781 reports involving serious injuries;
- 2,367 reports of hemorrhage;
- 542 patient deaths.
By comparison, Coumadin, which was second on the list of AERS in 2011, was linked to 1,106 injuries and 72 patient deaths.
Pradaxa is marketed as superior to Coumadin because it supposedly requires less follow-up patient monitoring. However, mounting reports of irreversible internal bleeding problems in patients being treated with the drug have caused widespread concern and led to investigations by health regulators in the United States, Europe and Canada.
Approved by the U.S. Food & Drug Administration (FDA) in October 2010, Pradaxa is the first in a new class of anticoagulants known as ‘direct thrombin inhibitors.’ However, drugmaker Boehringer Ingelheim has faced criticism and a number of Pradaxa lawsuits in recent months over their failure to adequately warn the public or medical community that the drug does not have a reversal agent to counteract internal bleeding events. With Coumadin, if bleeding events occur, doctors can reverse the effect with a single dose of vitamin K. Pradaxa has no such antidote.
One fundamental issue doctors have identified is testing of patients’ kidney function. Pradaxa is purged from the body by the kidneys, so if a patient has a problem with the organ that decreases its ability to function, the drug can build up in the blood and increase the likelihood of a bleeding event.
Following a comprehensive safety review of Pradaxa, the European Medicines Agency (EMA) decided not to issue a recall for the drug, but instead to recommend stronger label warnings about the bleeding risks, including specific guidance on when Pradaxa should not be used and how to manage internal bleeding events that do occur.
Do I Have a Pradaxa Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.