How Many Patients Died in a Trial Study of Pradaxa?
The anticoagulant Pradaxa was approved for use in the U.S. and Canada in 2010 based off a large global study called the RE-LY trial (the acronym for “Randomized Evaluation of Long-Term Anticoagulation Therapy). However, the original number of Pradaxa caused deaths in the study has increased.
This is the second time in four years that the authors of the RE-LY study have revised the number of deaths. According to The Hamilton Spectator, “the authors state a review of clinical trial data shows 20 additional deaths were found that should have been linked to adverse events in patients participating in the study.”
The authors also noted that lawyers for plaintiffs discovered seven other possible deaths linked to Pradaxa use. Of the 18,000 patients that took part in the RE-LY study, there were nearly 1,400 deaths.
Is There an Antidote for Pradaxa?
Pradaxa was approved as an alternative to the drug warfarin. Both of these drugs treat patients at risk of stroke caused by a type of heart arrhythmia called atrial fibrillation.
Decades prior to Pradaxa’s approval, warfarin was the popular anticoagulant of choice. Warfarin requires frequent blood monitoring, but there is an antidote if unexpected bleeding occurs.
Pradaxa is easier to manage, but it has no antidote for bleeding. This makes it very dangerous; once something goes wrong, it may result in severe adverse health risks or even death. Some of the health risks include:
- Brain hemorrhaging
- Internal kidney bleeding
- Gastrointestinal bleeding
- Internal bleeding
- Digestive track ulcers
Our attorneys have been working hard to investigate the health risks associated with Pradaxa use. If you have been injured by taking this anticoagulant, contact our firm at (888)841-9623.
Zoll & Kranz, LLC – Defective Medical Drug and Device Lawyers
ZK Law Note: According to The Hamilton Spectator, there is a worldwide clinical trial to test an antidote for Pradaxa to reverse cases of unexpected bleeding.