Quoted from http://www.reuters.com/article/2012/03/07/us-boehringer-pradaxa-idUSTRE8251MY20120307
Death magnifies Pradaxa hemorrhage concernsBy Ransdell Pierson(Reuters) - 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 a dangerous irregular heartbeat called atrial fibrillation that mostly affects the elderly.U.S. regulators said in December 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.
"In the event of traumatic hemorrhage in patients receiving dabigatran ... there are currently no effective reversal agents" to neutralize the drug, the report said.