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Thromb Haemost 2015; 113(04): 759-771
DOI: 10.1160/TH14-06-0514
Coagulation and Fibrinolysis
Schattauer GmbH

Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data

Cristina Solomon
1   CSL Behring, Marburg, Germany
2   Department of Anesthesiology, Perioperative Medicine and General Intensive Care, Paracelsus Medical University, Salzburg, Austria
,
Albrecht Gröner
1   CSL Behring, Marburg, Germany
,
Ye Jian
3   CSL Behring, King of Prussia, Pennsylvania, USA
,
Pendrak Inna
3   CSL Behring, King of Prussia, Pennsylvania, USA
› Author Affiliations Financial Support: The investigation was funded by CSL Behring. Editorial assistance with manuscript preparation was provided by Meridian HealthComms and funded by CSL Behring.
Further Information

Publication History

Received: 13 June 2014

Accepted after major revision: 22 October 2014

Publication Date:
24 November 2017 (online)

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Summary

Fibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, main-contribonding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.

Institution to which work should be attributed: CSL Behring, Marburg, Germany.

Keywords

Fibrinogen - pharmacovigilance - safety
 

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