Pro-Con Debate

Fibrinogen Concentrate or Cryoprecipitate for Treatment of Acquired Hypofibrinogenemia in Cardiac Surgical Patients

Nadia B. Hensley, MD; Michael A. Mazzeffi, MD, MPH, MSc, FASA


Anesth Analg. 2021;133(1):19-28. 

In This Article

Fibrinogen Concentrate Disadvantage: Off-label use

Another important limitation of fibrinogen concentrate is that its use in acquired hypofibrinogenemia is off-label in the United States. Although this may seem trivial, off-label drug use is associated with a 1.5-fold higher incidence of serious adverse drug events.[46] Furthermore, a significant amount of pharmacovigilance time may be needed to identify a pattern of increased thromboembolic risk. Recombinant activated factor VII is an excellent example of this phenomenon, where a clear pattern of increased thromboembolic risk was observed, as the drug was increasingly used off-label in the cardiac surgical patients.[47,48]