Everything You Wanted to Know about Pradaxa
By Christina Drury
There is no doubt that Pradaxa has been a hot topic in the news lately. Many people have suffered serious injury after using the prescription blood-thinner. It is commonly used in those who have atrial fibrillation or those who are at risk for developing blood clots and having subsequent strokes. Many articles online focus on the Pradaxa lawsuits that have been filed and the Pradaxa side effects that have led to serious injuries and even death. But it is important to know how it works and what has made it soar to the top of the FDA concerns list in a relatively short time. Introduction to Pradaxa
Pradaxa, as mentioned before, is an anticoagulant. It was approved for use in 2010 by the FDA as an alternative to another blood-thinner on the market, Coumadin — also known as warfarin. Warfarin had undergone media scrutiny due to the fact that it was causing complaints of internal bleeding and the FDA was looking to put a less risky type of medication on the market. Unfortunately, there has been speculation that the process of approval was rushed, and as a result Pradaxa has been a culprit in over 3,700 cases of reported injury including 542 deaths that occurred in 2011 alone.
Pradaxa Side Effects Cause for Concern
Setting the number of complaints aside, users of Pradaxa should be aware of the numerous Pradaxa side effects that can be caused just by taking the medication. Even adhering to the specific instructions for the prescription can lead to serious injury due to the nature of Pradaxa.
In addition to Pradaxa internal bleeding, which is the number-one reported Pradaxa side effect — and the one responsible for most of the reported deaths — Pradaxa use comes with other side effects as well. A study that was carried out by Cleveland Clinic came to the conclusion that the use of Pradaxa comes with it a 33% increase in heart attack compared to Coumadin.
The other thing that is necessary to note is that Pradaxa does not come with an antidote. Coumadin, should it cause internal bleeding, has one: Vitamin K. The Vitamin K can help reverse the effects of Coumadin, but Pradaxa patients will not have the same opportunity should Pradaxa internal bleeding occur.
The Dangers of Pradaxa Internal Bleeding
Pradaxa use has been tied to internal bleeding in the kidneys, brain and upper gastrointestinal area. With no known antidote to reverse these effects, it is nearly impossible to bring internal bleeding symptoms under control. As a result over 500 people have died simply by using Pradaxa as an anticoagulant.
Pradaxa internal bleeding can present itself in different ways — bloody stools or vomit being the main symptoms. If Pradaxa internal bleeding goes untreated for too long it can be fatal and oftentimes, it is not detected until it is too late — especially with no way to stop the bleeding.
While FDA reviews have shown that there is no known increased risk when using Pradaxa as compared to Coumadin, the fact remains that neither the deaths involved nor the fact that there is no antidote were used as factors in the review, essentially providing false results.
Updated December 17th, 2012
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