Pradaxa

Minor Trauma Led to Death in Pradaxa Patient

By Crystal Phend, Senior Staff Writer, MedPage Today

Published: March 06, 2012

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania.

Action Points

• Dabigatran etexilate is an oral anticoagulant that acts as a direct, competitive thrombin inhibitor. It does not require routine monitoring and has been approved by the FDA for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
• Note, however, that no effective reversal agent for dabigatran in the event of catastrophic hemorrhage has been identified.
• This case report indicates an example of catastrophic hemorrhage after mild traumatic brain injury, and the authors suggest measuring thrombin time and instituting the early use of dialysis in conjunction with intravenous fluid administration to maintain renal perfusion.

A dabigatran (Pradaxa) patient's death from a brain hemorrhage following a fall has again highlighted concerns over lack of an effective reversal agent for the drug.

Despite treatment with recombinant factor VII, the 83-year-old man deteriorated rapidly as the bleeding spread across most of the left hemisphere of his brain in just six hours, according to Richard H. Schmidt, MD, PhD, of the University of Utah in Salt Lake City, and colleagues./.../