Pradaxa Patient Died from Severe Brain Bleed Following Minor Trauma

The recent death of a man due to a brain hemorrhage caused by a minor trauma has underscored the dangers of the blood thinner drug Pradaxa.

According to a report at MedPageToday.com on a case study conducted by researchers at University of Utah-Salt Lake City, an 83-year-old man’s condition worsened quickly soon after he was admitted to a hospital after suffering a minor fall. Intracranial Bleeding brain had spread quickly to half his brain, taking just six hours.

Because there is no antidote to Pradaxa, doctors treating the man were short of answers on how to stop the excessive bleeding blamed on the relatively new drug, used to thin blood in an attempt to prevent fatal stroke or blood clots. Researchers completing the case study worry that Pradaxa’s increasing place on the U.S. marketplace as an alternative for the stand-by drug warfarin may lead to a higher number of people in this similar age bracket suffering the same fate due to a lack of knowledge on how best to treat patients who’ve suffered minor falls or brain trauma, even during minor or ordinary events.

Since there is no antidote to Pradaxa, physicians are urged to begin treating patients who present themselves after suffering these minor trauma immediately as if they are suffering from life-threatening bleeding episodes. According to Action Points included in the study, researchers suggest “measuring thrombin time and instituting the early use of dialysis in conjunction with intravenous fluid administration to maintain renal perfusion.”

Pradaxa was approved to prevent stroke by the Food and Drug Administration in 2010 and is an alternative therapy to warfarin, a drug used in similar indications since the 1950s. Pradaxa is prescribed to patients with a form of atrial fibrillation. It works by thinning the blood to prevent blood clots that are a leading cause in life-threatening stroke and heart attack.

The makers of Pradaxa have recently publicized more than 250 deaths among participants in a clinical trial of the drug but stopped short of saying this figure was above what they expected. Unlike warfarin, there is no antidote to remove the drug from the body, ending the threat caused from severe bleeding episodes caused by the drug.

Possible antidote agents like factor Vlla and fresh-frozen plasma have proven ineffective at stopping bleeding caused by Pradaxa. Researchers in Utah say dialysis in patients who’ve suffered mild brain trauma could help to remove most of the drug from the system but the decision to attempt this treatment in the recent case of death was done too late and by that time, the patient had lost too much blood. Dialysis with IV fluids can counter the effects of Pradaxa but patients with atrial fibrillation also face a risk impaired heart function if they are presented with a rush of fluids.

Even patients on Pradaxa who appear to have only suffered minor traumas after those falls may still be at risk of severe internal bleeding,including brain bleeds as was the case in the death reported in this study. When the patient was admitted to the hospital, he was alert and responsive and a CT scan revealed only minor internal brain bleeding. After just two hours however, the bleeding had spread to an entire hemisphere in his brain.

The Food and Drug Administration is currently conducting its own review of Pradaxa safety data after receiving enough reports of brain hemorrhaging and severe gastrointestinal bleeding among patients taking the drug.