Pradaxa patient's death draws more scrutiny of bleeding risks

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.

A Boehringer executive told Reuters that all anticoagulants carry a risk of bleeding, and in one large trial, Pradaxa patients had a 59% lower incidence of intracranial bleeding than warfarin patients did. But warfarin has an antidote--vitamin K--that can reverse its effects. Pradaxa and its new class of rivals do not.

Late last year, European regulators warned doctors to be cautious when using Pradaxa, particularly in patients with poor kidney function. Soon after, the FDA said it was reviewing reports of serious bleeding in patients using the drug. At the time, Boehringer pointed out that 1.1 million Pradaxa scripts were issued during its first 10 months on the market, saying that its "favorable safety profile" was "positive and ... unchanged."

- read the Reuters news