Dabigatran patient succumbs to fatal bleeding after minor fall

By: Alere Staff
Publication Date: Tue, 05/01/2012

The recent death of an 83 year old man using the new anticoagulation drug dabigatran (brand name Pradaxa® drug) is a reminder to healthcare providers and patients how drugs that prolong your bleeding time without an immediate and effective reversal agent are potentially dangerous.

After suffering a simple fall in his home with a minor head injury, the patient who was taking Pradaxa® 150mg twice/day, experienced a rapid decline in health status. The patient had a bleeding event inside his brain. Emergency room physicians immediately ordered a sensitive x-ray called a CT scan within 2 and 6 hours following his fall. Shortly after the second scan to evaluate the extent of the bleeding, the patient passed away.

This sad story explains and reinforces the fear physicians have in using new classes of drugs approved by the Food and Drug Administration (FDA) that perform a similar function as warfarin, but do not have a way to reverse or stop their effect.

In this case, physicians treated the patient in a manner consistent with standards of care. They gave him a product called recombinant factor VII administration which includes the body’s natural clotting factors to help stop the bleeding. However, treatment could not stop the patient’s bleeding.

An additional drastic procedure to stop these new classes of drugs includes a procedure called dialysis. The strategy for dialysis is to clear the drug from the body’s blood stream. Dialysis, however, appears to clear only 35-60% of dabigatran and takes 2-3 hours to perform.1

Any type of medication used to prolong your bleeding time to prevent dangerous blood clots from forming have the potential to cause a life-threatening bleed, including bleeding in the brain. Warfarin does have an advantage over new agents when it comes to reversing the drug’s effect. Vitamin K is commonly used to reverse the effect of too much warfarin. Vitamin K is administrated by a physician and is inexpensive compared to giving blood clotting factors or dialysis, but not effective with new drugs including dabigatran.

  1. Ganetsky M. Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant. J Med Toxicol 7:281–287, 2011.