Did the FDA Rush Approval of Pradaxa?
By Christina Drury
More worrisome news has surfaced about the prescription blood thinner, Pradaxa. According to an article published in Pharmalot on November 5, 2012, there is suspicion that the year-long study perpetrated by the FDA in regards to Pradaxa having similar health risks in line with other blood thinners may be unfounded. Several other publications in the medical industry have published similar articles that focus on the process in which the FDA approved Pradaxa. In light of several deaths caused by Pradaxa bleeding side effects, more information is coming to light about the manufacturer and how the FDA may have missed vital information in its analysis.
Results of the FDA Pradaxa Safety Study
The results of the FDA Pradaxa study – which was carried out by the Observational Medical Outcomes Project – were based on a risk analysis that has been used to form conclusions about the prescription drug Pradaxa. The article in Pharmalot states that the results published by the FDA add up to little more than a guess and that the study of the prescription blood thinner does not take into consideration the fact that Pradaxa has caused over 500 deaths in 2011 alone. Nor does the FDA mention that there is no antidote available for the internal bleeding caused by Pradaxa.
American Medical Association Shares Similar Concerns
In similar fashion to the article in Pharmalot, the American Medical Association (AMA) published in their journal that the FDA may have rushed through the approval process of Pradaxa and in the process missed out on key Pradaxa side effects, including internal bleeding amongst others.
The 542 deaths that were caused by Pradaxa side effects in 2011 were among the leading deaths caused by prescription medications. The Institute for Safe Medicine Practices estimates that the prescription drug Pradaxa is included in a group of prescription drugs responsible for an increase of 37% in complaints in the last few years.
Court Established to Handle Pradaxa Lawsuits
Due to the fact that there are so many active Pradaxa injury lawsuits, a central court in Illinois has been established to handle the various claims that are being filed due to Pradaxa side effects. The court issued an order – by Judge Herndon – that patients who suffered injuries due to Pradaxa side effects can proceed in filling their Pradaxa lawsuits. In addition, those who have lost loved ones due to fatalities can file on behalf of their estate.
It is important to work with an Pradaxa injury attorney who is already handling the Pradaxa lawsuits as they will be able to provide you with intimate knowledge of these specialized claims.
If you or someone you know has experienced any of the Pradaxa side effects, you should visit the Pradaxa Internal Bleeding Class Action Lawsuit Investigation page. On this page, you can send your personal information to attorneys who are already active in pursuing Pradaxa lawsuits against the manufacturer. There are several remedies that you may be entitled to, including compensation for injuries, economic injury due to loss of wages, wrongful death if you have lost a loved one due to Pradaxa side effects and more.
Updated December 5th, 2012
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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