PS-011. Skin necrosis after subcutaneously administered ceftriaxone: Cases notified to the French national pharmacovigilance database - Université de Picardie Jules Verne Accéder directement au contenu
Poster De Conférence Année : 2023

PS-011. Skin necrosis after subcutaneously administered ceftriaxone: Cases notified to the French national pharmacovigilance database

Résumé

Introduction: Following European Medicine Agency reassessment of its benefit/risk, ceftriaxone subcutaneous administration is no longer recommended in France since 2014. The safety of this route has been challenged due to serious adverse events (AE) such as skin necrosis, tolerance issues, and lack of route-specific studies backing it. However, this usage persists, mainly in elderly care [1,2] despite safety reminders from the French National Agency for the Safety of Medicines and Health Products. The objective of this study was to describe the cases of skin necrosis associated with subcutaneously administered ceftriaxone notified in the French national pharmacovigilance database (FNPD). Material and methods: We reviewed all the cases of skin necrosis after subcutaneous ceftriaxone administration reported to the FNPD from 1985 until July 2022. Results: 18 cases were analysed: The average age was 78.7 years old, included 72% women and 28% men. All cases were serious, among them 6 requiring hospitalization or extension of hospitalization. In all cases but one, ceftriaxone was the only suspected drug (one with co-suspected aminoglycoside). 17% of cases needed surgical care. The daily dosage was mainly 1 g (44%) and 2 g (33%). In 89% the solvent used was not reported (5% as recommended), and in 11% was lidocaine. Concomitants drug were glucose solution (17%), heparins (17%), vitamin K antagonist (11%). Skin necrosis spontaneously happened in 67% of cases. All cases had a favourable outcome. Discussion/Conclusion: We show here that skin necrosis after subcutaneous ceftriaxone should not be overlooked event if it is a rare AE regarding its reported frequent use. Its mechanism is still unknown. Our descriptive analysis remains limited to go further in this approach requiring additional data (such as histopathological, biological, administration parameters …). Only one published case provided histopathological data showing thrombosing vasculopathy of dermal vessels.

Dates et versions

hal-04265955 , version 1 (31-10-2023)

Identifiants

Citer

P. E. Pecquet, S. Laville, N. Massy, D. Dauge, J. Moragny, et al.. PS-011. Skin necrosis after subcutaneously administered ceftriaxone: Cases notified to the French national pharmacovigilance database. Annual Meeting of French Society of Pharmacology and Therapeutics, Jun 2023, Limoges (France), France. Fundamental and Clinical Pharmacology, 37 (S1), pp.92-209, 2023, ⟨10.1111/fcp.12908⟩. ⟨hal-04265955⟩
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