Wednesday, March 07, 2012

Pradaxa patient's death draws more scrutiny of bleeding risks - FiercePharma

The case of a Pradaxa user who died after a minor fall is raising more questions about the drug's safety. As the FDA investigates a series of deaths in Pradaxa patients, a new report in the Journal of Neurosurgery details an 83-year-old man's death from a small brain hemorrhage that quickly grew, and didn't respond to efforts to stop it.

"In the event of traumatic hemorrhage in patients receiving dabigatran ... there are currently no effective reversal agents," the report said (as quoted by Reuters). Because Boehringer Ingelheim's Pradaxa is cleared by the kidneys, dialysis has been suggested to neutralize its anticoagulant effects. This particular patient wasn't put on dialysis because "it was too late to implement effectively" as his condition rapidly deteriorated, the article states.

Posted via email from Jack's posterous

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