title: Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data.
abstract: BACKGROUND
  Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data.
  
  
  METHODS
  Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed.
  
  
  RESULTS
  Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile.
  
  
  CONCLUSIONS
  Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile.
authors: Medical Affairs Acquired Bleeding Disorders, CSL Behring, Marburg, Germany.
authors: Cristina
authors: C
authors: Solomon
authors: Hemostasis and Hemophilia Center; and Center for Laboratory Medicine, St. Gallen, Switzerland.
authors: Wolfgang
authors: W
authors: Korte
authors: Department of Anesthesia and Intensive Care, Medical University Innsbruck, Innsbruck, Austria.
authors: Dietmar
authors: D
authors: Fries
authors: CSL Behring, King of Prussia, PA, USA.
authors: Inna
authors: I
authors: Pendrak
authors: CSL Behring, Marburg, Germany.
authors: Christine
authors: C
authors: Joch
authors: CSL Behring, Marburg, Germany.
authors: Albrecht
authors: A
authors: Gröner
authors: Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr-University Bochum, Bad Oeynhausen, Germany.
authors: Ingvild
authors: I
authors: Birschmann
keywords: Factor XIII; Pharmacovigilance; Safety