A report released this week is raising more questions about the safety of the blood thinner, Pradaxa. The article, which was published in the Journal of Neurosurgery, describes the death of a Pradaxa patient who died from a cerebral hemorrhage following a simple fall. According to a Reuters report, the case study highlights the fact that Pradaxa bleeding side effects are largely irreversible.
Pradaxa, approved by the U.S. Food & Drug Administration (FDA) in October 2010, is used to prevent strokes in people with atrial fibrillation. It was expected to be adopted as a replacement for warfarin, which can have dangerous interactions with certain foods. However, in recent months, concerns have been mounting about potentially dangerous Pradaxa side effects. Late last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects. Regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.
According to Reuters, the Journal of Neurosurgery report details the worsening condition, and ultimate death, of an 83-year-old man at the University of Utah Medical Center. At first, the man’s case appeared to be that of a routine fall. Initially the patient was alert, and his neurological exam produced no concerns. CT scans revealed small, superficial areas of hemorrhaging in his brain.
However, within two hours his arrival at the hospital, new scans showed extensive progression of brain hemorrhaging, Reuters said. His doctors administered intravenous fluids and a protein called recombinant factor VIIa to stop his brain bleeding, but nothing worked. The man fell into a deep coma, and died shortly after.
As we’ve reported previously, there is no antidote for Pradaxa bleeding, as there is for the bleeding that often occurs with warfarin. According to Reuters, the authors of the report speculated that dialysis might remove 35 percent to 60 percent of Pradaxa from the bloodstream in two to three hour. However, by the time of the patient described in the report deteriorated, it was too late to implement that treatment effectively.
The authors of the article pointed out that because the elderly are more prone to balance problems and falls, cases of brain hemorrhage -even from a minor trauma – are likely to increase as more patients are prescribed Pradaxa.