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) 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.