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.

• Authors: Ignacio Colin-Bracamontes, Ángel Augusto Pérez-Calatayud, Raúl Carrillo-Esper, Ernesto Rodríguez-Ayala, Misael Padilla-Molina, Alejandro Posadas-Nava, Susana Olvera-Vázquez, Lidia Hernández-Salgado
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 40 Issue 5 Pg. 485-491 (May 2020) ISSN: 1179-1918 [Electronic] New Zealand
• PMID: 32215860 (Publication Type: Journal Article, Observational Study)

Chemical References

• Hemostatics
• Fibrinogen

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Child
• Child, Preschool
• Female
• Fibrinogen (adverse effects, therapeutic use)
• Hemorrhage (drug therapy)
• Hemostatics
• Humans
• Infant
• Infant, Newborn
• Male
• Mexico
• Middle Aged
• Pregnancy
• Prospective Studies
• Young Adult