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Case Study Reports Pradaxa Bleeding Death

Filed March 7th, 2012 Laurie

According to the Journal of Neurosurgery, the death of an elderly man who suffered a brain hemmorhage after a routine fall serves as proof that bleeding complications caused by Boehringer Ingelheim’s Pradaxa blood clot preventer are largely irreversible.

Pradaxa is the first in a new class of drugs known as direct thrombin inhibitors. The drug is approved to prevent strokes in patients that suffer with dangerous irregular heartbeat called atrial fibrillation. US regulators are also investigating other cases of bleeding associated with the medication. However, patients are still being told to continue taking it for now.

Researchers believe more deaths like the elderly man’s are likely to occur, considering balance and falls are common for elderly patients. Even the most minor trauma can cause brain hemorrhage. There is no antidote to Pradaxa that can control bleeding.

John Smith, senior vice president for clinical development at Boehringer Ingelheim, says that in a large clinical trial, patients taking Pradaxa had a 59 percent lower overall incidence of intracranial bleeding than patients taking warfarin.

The report says patients taking Pradaxa have a similar overall rate of brain hemorrhage as those taking warfarin, but have a lower annual incidence of stroke.

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