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Observational Safety Study of Clottafact® Fibrinogen Concentrate: Real-World Data in Mexico.

Abstract：

BACKGROUND AND OBJECTIVE:The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact® (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico. METHODS:This was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact® infusion. RESULTS:Information from 40 subjects was analyzed; 43% were women (n = 17), mean age was 39.05 ± 26.8 years (range 0-91 years). The medical specialties included in this analysis were cardiac surgery - 52.5% of the cases, gynecology/obstetrics - 17.5%, general surgery and orthopedics - 12.5% each, and hematology and neurosurgery - 2.5%, respectively. Mean plasma fibrinogen levels before and after Clottafact® infusion were 2.58 g/L and 4.02 g/L; p = 0.001, respectively. The mean Clottafact® dose was 2.20 ± 0.77 g. One patient presented SUSARs (dry mouth and dysgeusia) with drug administration, which ceased after treatment discontinuation. CONCLUSIONS:In this real-life post-marketing study, the safety profile of Clottafact® was very similar to previous reports. Thus, Clottafact® shows a favorable safety profile in clinical practice.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Colin-Bracamontes I,Pérez-Calatayud ÁA,Carrillo-Esper R,Rodríguez-Ayala E,Padilla-Molina M,Posadas-Nava A,Olvera-Vázquez S,Hernández-Salgado L

doi

10.1007/s40261-020-00906-6

subject

Has Abstract

pub_date

2020-05-01 00:00:00

pages

485-491

issue

5

eissn

1173-2563

issn

1179-1918

pii

10.1007/s40261-020-00906-6

journal_volume

40

pub_type

杂志文章

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