For the second time in four years, the authors of the RE-LY (Randomized Evaluation of Long-term anticoagulant therapY) Trial have revised the number of deaths (added 20) due to serious adverse events within the clinical trial that tested the drug on patients.
Pradaxa (dabigatran) is approved by the FDA for preventing stroke in nonvalvular atrial fibrillation only.
The RE-LY trial was divided in three arms: (18,000 patients in over 40 countries) - 1,400 died in the original trial.
- 110 mg dabigatran twice daily - 4 cases of life-threatening bleeding that led to three deaths
- 150 mg dabigatran twice daily - 4 cases cases of life-threatening bleeding that led to two deaths
- standard warfarin - 3 cases of life-threatening bleeding that led to all three dying
What is so great about dabigatran? There are no levels to manage as in warfarin. A patient has to endure weekly INR checks and adjustments along with monitoring other medications taken and diet to keep INR therapeutic. Dabigatran has no lab monitoring involved.
What is so bad about dabigatran? There is no antidote, so if you do get in a situation where you are bleeding, the consequences are much more dire. The company that makes dabigatran states they are working on developing an antidote but that even without one, they say they match warfarin's rate of death. According to the ISMP, 542 patients died in 2011 taking Pradaxa.
In the same category, Xarelto (rivaroxaban) is FDA approved to treat DVT and PE and prevention of stroke in nonvalvlular atrial fibrillation. Eliquis (apixaban) is FDA approved for DVT, nonvalvular atrial fibrillation and post-op venous thromboprophylaxis following hip or knee replacement surgery.
How could the FDA approve a medication without an antidote?