New Case Report About Routine Fall Involving An Elderly Patient That Results In Fatal Irreversible Brain Hemorrhage
Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription anticoagulant medication generically called dabigatran.
Pradaxa is a blood-thinning drug used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. Since coming on the market in October 2010 the FDA has received numerous Adverse Event Reports involving serious bleeding side effects such as hemorrhages.
This January 17, 2012 FDA approval letter to Boehringer Ingelheim shows the revisions to the Pradaxa Prescring Information, or label, that would be made in the U.S.
On March 21, 2012 Health Canada issued this advisory for health professionals, "Pradax (dabigatran etexilate) - Updated Labelling Regarding Kidney Function Assessment, and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves - Boehringer Ingelheim (Canada) Ltd.". It consisted of a so-called "Dear Doctor" letter which set forth some additions to the Pradaxa label in Canada; this letter from Boehringer Ingelheim began as follows:
March 16, 2012
Dear Health Care Professional,
Subject: Updated new recommendations for Pradax® (dabigatran etexilate) regarding renal function assessment, and use in patients with severe valvular disease or prosthetic heart valves.
Boehringer Ingelheim (Canada) Ltd., in consultation with Health Canada, would like to inform you of important new recommendations which have been added to the Product Monograph for Pradax® (dabigatran etexilate)....
Notably, there was no such announcement by the FDA concerning any Pradaxa "Dear Doctor" letter that may have been sent out in the U.S.
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Earlier in March 2012 there was a Reuters news report with this attention-getting headline, "Death magnifies Pradaxa hemorrhage concerns":
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....
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.
For more details about this fatal fall involving an elderly patient, see the original article published by the Journal of Neurosurgery, "Neurosurgical complications of direct thrombin inhibitors––catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran. Case report." (published ahead of print March 6, 2012).
We continue to watch for drug safety news regarding Pradaxa and will report significant developments, here.
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