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Elderly Man’s Death Highlights Serious Pradaxa Bleeding Risks

Elderly Man’s Death Highlights Serious Pradaxa Bleeding Risks

March 7, 2012 — Elderly people who fall may suffer severe, irreversible bleeding if they fall while taking Pradaxa, a common anti-clotting medication prescribed to prevent strokes caused by blood clots. Unlike warfarin, an older anti-clotting medication that was easily reversible with a dose of Vitamin K, the blood-thinning effects of Pradaxa can only be reversed with 2-3 hours of dialysis. The anti-clotting effect may cause unstoppable bleeding and death in people who suffer falls, accidents, or need an unexpected surgery.

The Journal of Neurosurgery recently published details of the death of an 83 year-old man who was using Pradaxa. Three doctors from the University of Utah cared for the man, who came to the hospital after a routine fall in which he hit his head. Initially, he was alert and could answer questions. Initial CT brain scans showed a small area of bleeding in his brain. Unfortunately, despite the doctors’ best efforts, they were unable to stop the bleeding in his brain. He lapsed into a coma and died.

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.

Because many older people have problems with balance, falls become more common with age. The researchers are concerned that fatal brain hemorrhages may become more common as the use of Pradaxa increases. The FDA is currently reviewing numerous reports of severe internal bleeding and hemorrhaging linked to Pradaxa.

Unfortunately, doctors must be familiar with Pradaxa bleeding risks in order to respond quickly and effectively when a patient comes in who is bleeding severely. The doctors treating the elderly man tried intravenous fluids and a protein called recombinant factor VIIa, but were unsuccessful. Researchers have hypothesized that dialysis could remove 30-60% of Pradaxa from a patient’s bloodstream, but the process would take several hours. It is likely that bleeding would cause severe harm before the dialysis could take effect.

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