Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P)

• Published in: Clinical and applied thrombosis/hemostasis Vol. 30; p. 10760296241254106
• Main Authors: Rahe-Meyer, Niels, Neumann, Gabriele, Schmidt, Dirk S, Downey, Laura A
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.01.2024; SAGE PUBLICATIONS, INC; SAGE Publishing
• Subjects: Afibrinogenemia - drug therapy; Female; Fibrinogen - administration & dosage; Fibrinogen - adverse effects; Fibrinogen - therapeutic use; Hemorrhage; Humans; Literature reviews; Male; Original; Retrospective Studies; Thromboembolism - etiology; adverse drug reaction; safety; fibrinogen concentrate; post-marketing
• ISSN: 1076-0296; 1938-2723; 1938-2723
• DOI: 10.1177/10760296241254106

Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP®/Haemocomplettan® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986–June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.