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Off‐label use of 4‐factor prothrombin complex concentrate is common despite little known benefit: A retrospective study
Author(s) -
Scharman Carlton D.,
Shatzel Joseph J.,
Kim Edward,
DeLoughery Thomas G.
Publication year - 2018
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.13105
Subject(s) - medicine , prothrombin complex concentrate , warfarin , retrospective cohort study , coagulopathy , off label use , limiting , hemostasis , prospective cohort study , incidence (geometry) , surgery , intensive care medicine , emergency medicine , mechanical engineering , physics , optics , engineering , atrial fibrillation
Background/Objective While four‐factor prothrombin complex concentrate (4F‐ PCC ) is FDA ‐approved for reversal of warfarin‐induced major bleeding, its use in real‐world settings is unclear. This study's objective was to identify indications leading to 4F‐ PCC use and associated outcomes at a single university hospital. Methods This was a retrospective cohort study of patients receiving 4F‐ PCC over a 22‐month period. A dose was “on‐label” if given for reversal of warfarin‐induced coagulopathy in patients with major bleeding or requiring urgent surgeries/procedures; other doses were “off‐label”. Results A total of 165 doses of 4F‐ PCC in 154 patients were given. Sixty‐one percent of doses were on‐label, while 39% were off‐label. Intracranial hemorrhage was the most common indication (55% of doses). On‐label patients had significantly higher rate of INR normalization and survival to hospital discharge than off‐label patients. There was no difference in time to INR normalization, time to hemostasis, or incidence of thromboembolic complications. Conclusions Off‐label use of 4F‐ PCC is likely common, occurring in nearly 40% of drug administrations at our center. Larger‐scale prospective trials studying specific indications are needed for validation in off‐label settings. Until such evidence is available, given potential harms historically displayed by off‐label use of other hemostatic agents, limiting off‐label 4F‐ PCC use is recommended.