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Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P).
Niels Rahe-Meyer1,2, Gabriele Neumann3, Dirk S Schmidt4
1Department for Anaesthesiology and Intensive Care Medicine, Franziskus Hospital Bielefeld, Bielefeld, Germany.
Summary
Fibrinogen concentrate effectively treats bleeding in patients with fibrinogen deficiency. Post-marketing data and studies show a low risk of adverse drug reactions, including thromboembolic events, supporting its favorable safety profile.
Area of Science:
- Hematology
- Pharmacovigilance
Background:
- Fibrinogen concentrate is recommended for acute bleeding in patients with fibrinogen deficiency.
- Concerns exist regarding the risk of thromboembolic events (TEEs) following fibrinogen concentrate treatment.
Purpose of the Study:
- To evaluate the post-marketing safety of fibrinogen concentrate (RiaSTAP®/Haemocomplettan® P).
- To assess the risk of TEEs associated with fibrinogen concentrate use.
Main Methods:
- Retrospective analysis of post-marketing data (1986-2022) for fibrinogen concentrate administration.
- Literature review of published studies, including randomized controlled trials, on fibrinogen concentrate use.
Main Results:
- Approximately 7.45 million grams of fibrinogen concentrate were administered.
- Adverse drug reactions (ADRs) were reported in 337 patients; 81 experienced possible TEEs, with 14 fatal outcomes.
- Most TEEs had confounding factors; comparative studies generally showed lower ADR/TEE rates with fibrinogen concentrate.
Conclusions:
- Post-marketing data and clinical studies indicate a low rate of ADRs, including TEEs, with fibrinogen concentrate.
- Fibrinogen concentrate demonstrates a favorable safety profile for managing intraoperative bleeding.
