Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data.

Autor: Solomon C; Medical Affairs Acquired Bleeding Disorders, CSL Behring, Marburg, Germany., Korte W; Hemostasis and Hemophilia Center; and Center for Laboratory Medicine, St. Gallen, Switzerland., Fries D; Department of Anesthesia and Intensive Care, Medical University Innsbruck, Innsbruck, Austria., Pendrak I; CSL Behring, King of Prussia, PA, USA., Joch C; CSL Behring, Marburg, Germany., Gröner A; CSL Behring, Marburg, Germany., Birschmann I; Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Jazyk: angličtina
Zdroj: Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie [Transfus Med Hemother] 2016 Sep; Vol. 43 (5), pp. 365-373. Date of Electronic Publication: 2016 Aug 03.
DOI: 10.1159/000446813
Abstrakt: 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.
Conclusion: Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile.
Databáze: MEDLINE