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Medical Journal Details Pradaxa Bleeding Death Of Elderly Man Following Fall

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Medical periodical, the Journal of Neurosurgery, has detailed the Pradaxa bleeding death of an elderly man. Pradaxa (dabigatran), approved in 2010, is manufactured by Boehringer Ingelheim and is a recently approved medication in the class known as direct thrombin inhibitors used to prevent strokes in patients diagnosed with atrial fibrillation.

The man died after a fall, said Reuters, and the complications from his fall point to potentially irreversible bleeding complications associated with Pradaxa, according to the Journal of Neurosurgery.

According to Reuters, three physicians from the University of Utah monitored and documented the deterioration and death of the 83-year-old man who was evaluated at the University of Utah’s medical center following a routine fall, according to the report, said Reuters.

At first, the man was fully alert and oriented, was responding to verbal commands; the man’s neurological exam indicated no issues of concern, said the doctors, wrote Reuters. CT scans did reveal “small, superficial” brain hemorrhage areas, but within two hours of his arriving at the hospital, scans revealed “extensive progression of brain hemorrhaging” in the patient, said Reuters.

The hospital was unable to stop the hemorrhage, using methods that include the administration of intravenous fluids and the protein, recombinant factor VIIa. The man lapsed into a deep coma and died, said the report. “In the event of traumatic hemorrhage in patients receiving dabigatran … there are currently no effective reversal agents” to neutralize the drug, the team said, according to Reuters.

The report urged better familiarity with Pradaxa so that swift action can be taken to control catastrophic bleeding. The researchers discussed the potential that dialysis could have removed 35-60% of Pradaxa from the bloodstream in two-three hours, but that step was not taken with the man in this case. “By the time of his deterioration it was too late to implement effectively,” the team noted, wrote Reuters.

Late last year, the U.S. Food & Drug Administration (FDA) said it was conducting a safety review of Pradaxa and was seeking to learn if serious bleeding is occurring in Pradaxa patients more commonly than initially expected. The FDA’s Drug Safety Communication indicated that the agency was evaluating post-marketing reports of serious bleeding events in Pradaxa.

Just prior, Boehringer Ingelheim, said it received 260 reports of fatal bleeding among Pradaxa patients worldwide, including 21 in Europe, all between March 2008 and October 31, 2011.

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