Observational Safety Study of Clottafact® Fibrinogen Concentrate: Real-World Data in Mexico
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) fibrinoge...
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Published in | Clinical drug investigation Vol. 40; no. 5; pp. 485 - 491 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Cham
Springer International Publishing
01.05.2020
Springer Nature B.V |
Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 |
ISSN: | 1173-2563 1179-1918 |
DOI: | 10.1007/s40261-020-00906-6 |