March 7, 2012 — The Journal of Neurosurgery has published a report of an elderly man who died of severe bleeding in the brain after a minor fall in which he hit his head. The man was taking Pradaxa (dabigatran), a common anti-clotting medication used to prevent strokes.
Unfortunately, only 2-3 hours of dialysis can remove Pradaxa from a person’s bloodstream and halt the blood-thinning effects. Without dialysis, it may be difficult or impossible for a doctor to stop the bleeding. This can cause severe, uncontrollable bleeding that causes death. As the use of Pradaxa increases among the elderly, doctors are concerned that this drug may cause more and more cases of fatal brain hemorrhages in the future.
The authors of the report were three doctors from the University of Utah. They treated an 83 year-old man who hit his head in a minor fall. When the man initially came to the hospital, he could answer questions and was alert. Doctors began treatment with a CT brain scan, which revealed a small area of bleeding in the man’s brain.
The doctors used traditional treatments to stop this bleeding. They gave the man intravenous fluids and a protein called recombinant factor VIIa, which normally stops bleeding. The man did not respond to this treatment. The bleeding became more severe, he lapsed into a coma, and died soon after. The doctors hypothesized that if they had put the man on dialysis immediately when he came to the hospital, the dialysis could have removed 30-60% of Pradaxa from his bloodstream, but it would have taken 2-3 hours. By this time, it is likely that he would have suffered severe bleeding.
In the report, the doctors said: “In the event of traumatic hemorrhage in patients receiving dabigatran … there are currently no effective reversal agents” to neutralize the drug.
Pradaxa was developed as an alternative to warfarin, an anti-clotting stroke-prevention medication that has a long history of use. Warfarin is a particularly cumbersome medication, because it carries a high risk of bleeding, requires blood testing to adjust dosage, and interacts with many foods containing Vitamin K. The effects of warfarin can be easily reversed with a dose of Vitamin K. With Pradaxa, however, only dialysis can reverse the anti-clotting effects of the medication. This can cause serious problems when a patient suffers a fall, accident, or requires unexpected surgery for an injury, because a doctor may be unable to stop severe bleeding.
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