Delayed thrombocytopenia following administration of abciximab: Pharmacovigilance survey and literature review.

Therapie

Department of Pharmacology, Toxicology and Pharmacovigilance, Angers University Hospital, 4, rue Larrey, 49933 Angers, France; University of Angers, 49933 Angers, France; MitoVasc Laboratory, UMR CNRS 6214 Inserm 1083, 49933 Angers, France.

Published: November 2021

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: 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: 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/L (range 1-110) with a majority of grade 4 thrombocytopenia (39.5%). The literature review identified 42 cases and provided additional information on administered therapies, which include platelet units, corticosteroids, and IV immunoglobulins. GPIIb/IIIa-ABX complex antibodies were described in 26 published cases.

Conclusion: 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.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.therap.2021.02.006DOI Listing

Publication Analysis

Top Keywords

delayed thrombocytopenia
12
literature review
12
pharmacovigilance survey
8
pharmacovigilance database
8
selected vigibase®
8
icsrs french
8
french cases
8
platelet count
8
thrombocytopenia
5
delayed
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!