A recent report filed by the Institute for Safe Medicine Practice (ISMP) claims that abnormally high numbers of Pradaxa complications have been present in test studies. The report claims that only a few weeks after being approved for use in October 2010, Pradaxa jumped near the top of the Institute for Safe Medicine Practice (ISMP) adverse event rankings in drugs.
The ISMP reports that there are more adverse Pradaxa complication reports than 98.7% of the other drugs that they study over the same period of time. Most of the adverse Pradaxa complications stemmed from Pradaxa’s anticoagulant properties. The report claims that there were cases where Pradaxa both inhibited blood clotting excessively which led to uncontrolled bleeding as well as not having enough clotting effect which allowed blood clots to continue to form in Pradaxa patients.
The Institute for Safe Medicine Practice (ISMP) focused their report on three main issues with Pradaxa: inhibiting blood clotting in the older populous who have heart problems which remains inherently risky, the rapid nature of Pradaxa’s release which has generated scores of adverse Pradaxa complication reports within weeks of Pradaxa’s approval, and finally that the drug was immediately put in to use on an off-label basis.
A mere 12 weeks after its approval in October 2010, Pradaxa was the suspect drug in more than 300 adverse event reports, which was more than 98.7% of the other drugs being monitored by the Institute for Safe Medicine Practice (ISMP) at that time. The drugs being monitored also included warfarin which Pradaxa is meant to replace. Pradaxa had 50% more adverse event reports than warfarin.
Pradaxa was approved in order to lower the risk of stroke in patients suffering from atrial fibrillation, a heart arrhythmia disorder located in the upper two pumping chambers in the heart. If those chambers stop working correctly, it can raise the risk of blood clot formation. If these blood clots reach the brain they can cause a stroke which can lead to serious injury or death.
The primary problem with warfarin was that it is supposed to be very difficult to dose. It is hard to determine the exact amount of the drug that a patient needs to prevent clots and not overly thin the blood. It requires frequent lab testing. Clinical trials showed that Pradaxa appeared to have a solution for that issue. However, a large clinical trial which compared Pradaxa and warfarin showed that Pradaxa did not lower the risk of bleeding.
Pradaxa Complications Lawsuit
If you have a loved one who has suffered a Pradaxa-related death, you may be entitled to financial compensation from the makers of Pradaxa, Boehringer Ingelheim. Numerous reports have arisen about the dangers of Pradaxa, and that it may cause uncontrolled bleeding among patients which has led to Pradaxa deaths.
Within its first year on the market there have been more than 260 reported Pradaxa deaths. We believe that number is far too high, and you may be entitled to compensation if you or a loved one has suffered from Pradaxa from:
- Internal Bleeding
- Cerebral Hemorrhaging
- Heart Attack
- Death
Please contact our law firm to speak with a lawyer to determine if you have a case against the makers of Pradaxa.