On March 6, 2012, the Journal of Neurosurgery (JNS) published a report that Pradaxa may be responsible for irreversible bleeding complications after an elderly gentleman died as a result of a brain hemorrhage.

Pradaxa (dabigatran), manufactured by Boehringer Ingelheim, is a prescription blood thinner medication. Pradaxa is part of a new class of medications recently approved by the US Food and Drug Administration (FDA) to prevent strokes in patients with atrial fibrillation which is the most common type of heart rhythm abnormality especially among the elderly. This new class of drugs was developed to replace the use of warfarin (Coumadin), which has a high risk of bleeding and needs to be closely monitored.

The 83 year old man mentioned in the JNS report was treated at the University of Utah medical center after a routine fall. Initial evaluations showed serious complications, however two hours later CT scans indicated extensive brain hemorrhaging. Doctors were unable to stop the hemorrhaging and patient died as a result of the hemorrhaging. Unfortunately, falls are commonplace among the elderly which raises concerns that many who take Pradaxa for stroke prevention may instead suffer from serious bleeding risks.

While warfarin and Pradaxa may both have serious bleeding risks, there are measures that can be taken to negate any severe bleeding that may occur as a result of using warfarin. There are no such methods to date with Pradaxa. “In the event of traumatic hemorrhage in patients receiving dabigatran … there are currently no effective reversal agents” to neutralize the drug, the report said.