Pradaxa is the first blood thinner approved since 1954. It was approved to reduce the risk of deadly strokes in patients suffering from a form of irregular heartbeat, atrial fibrillation, but the drug has potentially deadly side effects. As a blood thinner, Pradaxa can cause serious, even deadly bleeding. And Pradaxa has no antidote, and no good monitoring method, unlike the alternative drug warfarin, so there is a possibility the drug may put certain people at a higher risk than the standard treatment. Even in the short time it has been approved—just over a year–the drug has been associated with 500 severe hemorrhages, some fatal, among other adverse events.
If you have suffered serious injury or lost a loved one after taking Pradaxa, you may be able to receive compensation for your injuries. To learn more about your legal rights, please contact a local personal injury lawyer for a free case evaluation today.
What Is Pradaxa?
Pradaxa is an antithrombotic, a blood thinner that was approved in October 2010for stroke prevention in atrial fibrillation patients with atrial fibrillation. Pradaxa is the vanguard in a wave of blood thinners intended to replace the current standard of care, warfarin, a drug that has been used successfully but problematically in the US since 1954.
Pradaxa promised several benefits over warfarin, which, incidentally, is also used as a rat poison, including:
- No regular testing necessary
- No dietary or drug interactions, that are known
- Quicker action
Because of these benefits, the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society all adopted Pradaxa as the standard of care in their guidelines.
However, Pradaxa is not without serious risk. In fact, one of its stated benefits can also make it a dangerous drug. There is no way to test how well Pradaxa is working. This may lead to a problem of control because doctors may not know how well a patient is complying with the twice-a-day regimen to maintain the drug’s effects. It also means some patients may experience too large a dose, especially patients with reduced kidney function. Because Pradaxa is eliminated through the kidneys, poor kidney function can cause drug levels in the blood to rise, potentially leading to very thin blood and potential dangerous bleeding.
Another danger of Pradaxa is that the drug has no antidote. Once a patient begins to suffer adverse bleeding from Pradaxa, there is no way to stop it, unlike warfarin, whose effects can be reduced by a dose of vitamin K.
European officials have stated reports of 256 fatal bleeding events from the drug. These events occurred worldwide, but now officials recommend that doctors prescribe the drug with caution for elderly patients or patients with reduced kidney function.
The FDA has not released the number of adverse event reports it received (the number above comes from an independent review of the FDA’s system). FDA experts admit to reviewing the potential risk of serious bleeding events. The FDA currently believes the benefits of Pradaxa outweigh its risks.
Compensation for Pradaxa Injuries
We do not yet know how many people have suffered serious bleeding events as a result of Pradaxa use. You can help us understand the magnitude of this problem and receive compensation for injuries. If you have suffered an injury, make sure your doctor reports it to the FDA and consider a lawsuit to receive compensation for your injuries.
To learn more about your legal options after an injury related to Pradaxa, pleasecontact a local personal injury lawyer.