title: Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data.
abstract: 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, corresponding 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.
authors.affiliation: Assoc. Prof. Cristina Solomon, MD, MBA, CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany, Tel: +49 6421 39 5813, Fax: +49 6421 39 4146, E-mail: Cristina.Solomon@cslbehring.com.
authors.forename: C
authors.initials: C
authors.lastname: Solomon
authors.forename: A
authors.initials: A
authors.lastname: Gröner
authors.forename: J
authors.initials: J
authors.lastname: Ye
authors.forename: I
authors.initials: I
authors.lastname: Pendrak
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D004340:Drug Contamination; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000209:etiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000209:etiology*; D005260:Female; D005340:Fibrinogen / Q000009:adverse effects*; D006490:Hemostatics / Q000009:adverse effects*; D006509:Hepatitis B / Q000635:transmission; D006526:Hepatitis C / Q000635:transmission; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D060735:Pharmacovigilance; D018570:Risk Assessment; D012307:Risk Factors; D013923:Thromboembolism / Q000139:chemically induced / Q000175:diagnosis; D013997:Time Factors; D055815:Young Adult
chemical_list: D006490:Hemostatics; D005340:Fibrinogen
keywords: Fibrinogen; pharmacovigilance; safety