ArticleTransfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie2016
Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data.
Article in Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 25 citations in OpenAlex.
- Recombinant FXIII (rFXIII-A2) Prophylaxis Prevents Bleeding and Allows for Surgery in Patients with Congenital FXIII A-Subunit Deficiency.Thrombosis and haemostasis · 2018Trial
- Factor XIII Supplementation in Postpartum Hemorrhage: From Biological Rationale to Clinical Implementation.American journal of hematology · 2026Review
- Factor XIII Deficiency: A Review of Biology, Testing, and Treatment.Clinical hematology international · 2026Review
- Factor XIII deficiency: an updated approach to diagnosis and management.Frontiers in medicine · 2026Review
- Factor XIII: More than just a fibrin stabilizer for the burn patient? A matched-pair analysis.JPRAS open · 2023Article
- A multicenter, real-world experience with recombinant FXIII for the treatment of patients with FXIII deficiency: from pharmacokinetics to clinical practice. The Italian FXIII Study.Blood transfusion = Trasfusione del sangue · 2023Article
- Factor XIII in the Acute Care Setting and Its Relevance in Obstetric Bleeding.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023Review
- The pharmacokinetics of recombinant FXIII (catridecacog) from the MENTORJournal of thrombosis and thrombolysis · 2022Article
- The impact of acquired coagulation factor XIII deficiency in traumatic bleeding and wound healing.Critical care (London, England) · 2022Review
- Hemorrhagic Shock after Neonatal Circumcision: Severe Congenital Factor XIII Deficiency.Case reports in pediatrics · 2021Article
- Effectiveness of Factor XIII Infusion in Treatment of Refractory Ureteral Leakage after Kidney Transplantation.Case reports in transplantation · 2020Article
- Article
- Spontaneous subdural hematomas particularly with a decreased coagulation factor XIII activity require follow-ups of the neuroradiological diagnostic.Neuroradiology · 2017Article
- Acquired Factor XIII Deficiency in Critical Care: Registry-Based Analysis of Features, Symptoms and Risk Factors.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
- Mild Acquired Factor XIII Deficiency and Clinical Relevance at the ICU-A Retrospective Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPlasma-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.
methodsPostmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed.
resultsCommercial 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.
conclusionAssessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile.
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