Pradaxa was approved by U.S. regulators in October 2010 for stroke prevention in patients with atrial fibrillation. It is the first of a new crop of blood clot preventers meant to replace warfarin -- a longtime oral treatment that carries serious bleeding risks and requires routine blood monitoring and stringent dietary restrictions.
The death of an elderly man from a massive brain hemorrhage after a routine fall suggests that bleeding complications from Boehringer Ingelheim's Pradaxa blood clot preventer are largely irreversible, according to the Journal of Neurosurgery.
The recently
approved drug is the first in a new class of oral medicines called
direct thrombin inhibitors, approved to prevent strokes among patients
with an irregular heartbeat called atrial fibrillation that mostly affects the elderly.
U.S. regulators in
December said they were evaluating other cases of bleeding associated
with the drug, whose chemical name is dabigatran, but advised patients
to continue the medicine for now.
Three doctors from
the University of Utah monitored and described the worsening condition,
and ultimate death, of the 83-year-old man who was evaluated at their
medical center for what seemed at first a rather routine fall, according to the report Tuesday in the journal's online edition.
Initially, the patient was fully alert and oriented and
could respond to verbal commands, and his neurological exam produced no
findings of great concern, the clinicians said.
They said CT scans revealed small, superficial areas of hemorrhage
in his brain, but that within two hours after arriving at the hospital
new scans showed extensive progression of brain hemorrhaging.
Efforts to stop the
hemorrhaging, including intravenous fluids and a protein called
recombinant factor VIIa, proved ineffective and the patient fell into a
deep coma and died soon afterward, the report said.
http://news.yahoo.com/death-magnifies-pradaxa-hemorrhage-concerns-221933716.html
