A recent analysis of internal bleeding injuries among Pradaxa (generic: dabigatran) users is the latest medical evidence suggesting that the risks of the controversial new medication may be greater than any potential benefit.
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?
March 8, 2012 – The new review, which was published in last month’s online edition of the Journal of the American College of Cardiology, identified 78 internal bleeding events over the course of the 60 day review period, including 44 cases handled by the panelists personally. Of these 44, a dozen were classified as ‘severe.’
One of the major contributing factors to the internal bleeding events identified by the panel was that of prescriber error. A number of doctors were found to have prescribed Pradaxa to patients with pre-existing kidney damage, which has previously been identified as being one of the four major factors contributing to internal bleeding. Impaired renal function makes it difficult for the body to filter out Pradaxa’s blood-thinning agents, thereby increasing the chance that internal bleeding events will become progressively severe. In the RE-LY clinical trial, which the FDA used as justification for Pradaxa’s approval, less than 20% of the test subjects had prior kidney damage, compared to nearly 60% of the population from the new review.
Another major contributing factor identified by the panel was the issue of patient age. The average test subject age in the RE-LY trial was 71-years-old, and less than 30% of the population was over the age of 80. In the new study, more than two-thirds of the test subjects were older than 80-years-old. This is an important distinction due to the fact that moderate kidney damage is reported in approximately half of all patients with atrial fibrillation (the condition for which Pradaxa is most often prescribed), and who are older than 80. As discussed above, pre-existing renal impairment increases the chance that a bleed will become severe.
Because the test subjects reviewed by the new study have significantly different demographics from that of the RE-LY trial, the panelists encouraged further investigation into the matter, and advised those who prescribe Pradaxa to weigh the risks versus benefits of the medication with patients carefully – especially in individuals over 80 or with pre-existing kidney damage – before prescribing the drug.
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.