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Case Study Points to Pradaxa Traumatic Bleeding Dangers

Mar 30, 2012 | Parker Waichman LLP

A case study published earlier this in the Journal of Neurosurgery highlighted the risk elderly Pradaxa patients could face from only a minor trauma.  The report detailed the death of an 83-year-old Pradaxa patient from a traumatic brain bleed that followed a minor fall. 

The report is disturbing because many of the people taking Pradaxa are elderly.  And this population often experiences balance problems and other disorders that make them susceptible to falls and minor traumas.  Many older people also suffer from kidney problems, and need more time to eliminate Pradaxa from their system.

This is especially problematic because there is no antidote available to put an end to Pradaxa bleeding. Dialysis with IV fluids can counter the effects of Pradaxa but patients with atrial fibrillation also face a risk impaired heart function if they are presented with a rush of fluids.

When the patient in the case study was admitted to the hospital, he was alert and responsive and a CT scan revealed only minor internal brain bleeding. After just two hours however, the bleeding had spread to an entire hemisphere in his brain. Dialysis in patients who’ve suffered mild brain trauma could help to remove most of the drug from the system but the decision to attempt this treatment in this case was done too late and by that time, the patient had lost too much blood.

The Food and Drug Administration is currently conducting a review of Pradaxa safety data after receiving enough reports of brain hemorrhaging and severe gastrointestinal bleeding among patients taking the drug.  In November, the maker of Pradaxa said it had received 260 reports of fatal bleeding among Pradaxa patients. 

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