4-Factor Prothrombin Complex Concentrate Approved
Hello. This is Dr. Sam Goldhaber from the Clotblog at theheart.org, speaking to you from Brigham and Women's Hospital and Harvard Medical School on the important topic of 4-factor prothrombin complex concentrate (4F-PCC), which is the optimal approach to urgent warfarin reversal.
The US Food and Drug Administration only recently approved 4F-PCC to reverse excessive bleeding from warfarin. We have had 3-factor PCC around for a long time but it doesn't have much factor VII in it. Our European colleagues have had 4F-PCC for the past few years.
I was very pleased recently to have had the opportunity to use 4F-PCC to reverse an intracranial hemorrhage in a patient who had an international normalized ratio (INR) of 2.8 and a spontaneous head bleed. She was receiving warfarin for anticoagulation, and within about 15 minutes the 4F-PCC, along with 10 mg of intravenous vitamin K, returned her INR to normal. Of greater importance, the head bleeding stopped and she regained virtually all of her neurologic function. It seemed miraculous to me and it happened so quickly that it was very gratifying.
Almost simultaneously with my clinical experience, we published an observational study in Circulation with about 300 patients who bled on warfarin. Approximately 80% of these patients were on warfarin because of permanent atrial fibrillation, and they had an average age in the 70s. Initially patients received fresh frozen plasma (before 4F-PCC became available in Canada) and their outcomes with fresh frozen plasma were tracked very carefully. When 4F-PCC came along and practice switched to that therapy, those outcomes were tracked as well.
Cite this: Rapid Warfarin Reversal With 4-Factor Prothrombin Complex Concentrate - Medscape - Nov 07, 2013.