Delayed thrombocytopenia following administration of abciximab: Pharmacovigilance survey and literature review.
Abciximab
Acute coronary syndrome
Antiplatelet drugs
Bleeding
Pharmacovigilance
Thrombocytopenia
Journal
Therapie
ISSN: 1958-5578
Titre abrégé: Therapie
Pays: France
ID NLM: 0420544
Informations de publication
Date de publication:
Historique:
received:
19
09
2020
revised:
15
01
2021
accepted:
16
02
2021
pubmed:
18
3
2021
medline:
24
11
2021
entrez:
17
3
2021
Statut:
ppublish
Résumé
Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24hours. The aim of this study was to evaluate, in a context of pharmacovigilance survey, the occurrence of delayed thrombocytopenia following ABX infusion in pharmacovigilance database reports and in the literature. Individual case safety reports (ICSRs) of delayed thrombocytopenia-between 3 and 30 days - with ABX presented as a single suspect were selected in VigiBase®, the WHO global database of ICSRs. The French cases were then extracted from the French national pharmacovigilance database. In addition, a literature review of published cases was performed using PubMed. Among the 84 ICSRs selected from VigiBase®, 43 were also reported in the FPVD. Mean age was 60.1±12.3 years with a majority of male patients (77.4%). The average time to onset (TTO) was 8.9±5.2 days. Thrombocytopenia regressed in 5.1±2.7 days. Haemorrhagic complications were reported in 15% of ICSRs. In the French cases, the median nadir of platelet count was 28×10 Delayed thrombocytopenia, probably due to immune reaction, is a possible life-threatening adverse effect of ABX with a mean TTO of 9 days, supporting the recommendation of a platelet count monitoring during at least two weeks. This recommendation was added to the abcximab SmPC in 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24hours. The aim of this study was to evaluate, in a context of pharmacovigilance survey, the occurrence of delayed thrombocytopenia following ABX infusion in pharmacovigilance database reports and in the literature.
METHODS
METHODS
Individual case safety reports (ICSRs) of delayed thrombocytopenia-between 3 and 30 days - with ABX presented as a single suspect were selected in VigiBase®, the WHO global database of ICSRs. The French cases were then extracted from the French national pharmacovigilance database. In addition, a literature review of published cases was performed using PubMed.
RESULTS
RESULTS
Among the 84 ICSRs selected from VigiBase®, 43 were also reported in the FPVD. Mean age was 60.1±12.3 years with a majority of male patients (77.4%). The average time to onset (TTO) was 8.9±5.2 days. Thrombocytopenia regressed in 5.1±2.7 days. Haemorrhagic complications were reported in 15% of ICSRs. In the French cases, the median nadir of platelet count was 28×10
CONCLUSION
CONCLUSIONS
Delayed thrombocytopenia, probably due to immune reaction, is a possible life-threatening adverse effect of ABX with a mean TTO of 9 days, supporting the recommendation of a platelet count monitoring during at least two weeks. This recommendation was added to the abcximab SmPC in 2019.
Identifiants
pubmed: 33726948
pii: S0040-5957(21)00074-3
doi: 10.1016/j.therap.2021.02.006
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Immunoglobulin Fab Fragments
0
Platelet Aggregation Inhibitors
0
Abciximab
X85G7936GV
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
687-693Informations de copyright
Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.