Pradaxa Brain Hemorrhage Report Highlights Risks with New Drug

The lack of a fast method to reverse the bleeding side effects of Pradaxa is proving lethal to many patients, according to a newly published case study. 

In a report published Tuesday in the Journal of Neurosurgery, researchers highlight the risk associated with hemorrhages from Pradaxa, as the newer blood thinner does not have a “reversing agent” that allows doctors to stop the bleeding.

Three doctors from the University of Utah’s Department of Neurosurgery present the story of an 83 year-old man who died from a brain hemorrhage caused by Pradaxa. The man was given the blood thinner following a minor head injury sustained in a fall at his home. Doctors prescribed Pradaxa to restore blood flow fully to the brain.

Just six hours after Pradaxa was administered, a CT scan showed extensive brain hemorrhaging. The doctors determined there was nothing they could do to save his life due to the lack of a reversal agent for Pradaxa and met with his family to discuss putting him into comfort care where he died shortly afterward.

Pradaxa (dabigatran) is a newer blood thinner, which was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations.  However, there have been a staggering number of reports involving hemorrhages among users of the medication, including hundreds of deaths from Pradaxa.

Among users of the older, more widely-used blood thinner Coumadin, known generically as warfarin, bleeding events can be addressed by giving the patient a dose of Vitamin K. Although Pradaxa has been promoted as a superior medication because it requires less monitoring, internal bleeding problems can not be reversed if they do occur.

“There is currently no effective antidote to reverse the anticoagulant effect of dabigatran in the event of an emergency,” the researchers wrote. “Dabigatran is only the first of several direct thrombin inhibitors that may enter clinical use and these agents will likely have similar risks for catastrophic progression of traumatic injuries.”

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

A number of individuals throughout the United States are now considering a Pradaxa lawsuit against the drug maker for failing to adequately research the medication or warning about the risk of serious and potentially life-threatening health risks of Pradaxa.