| アブストラクト | 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(R), 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(R), 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 28x10(9)/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. |
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| 投稿者 | Vincent, Louis; Bourneau-Martin, Delphine; Maurier, Anais; Babin, Marina; Delepine, Stephane; Helley, Dominique; Grandvuillemin, Aurelie; Lagarce, Laurence; Lillo-Le Louet, Agnes; Briet, Marie |
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| 組織名 | Department of Pharmacology, Toxicology and Pharmacovigilance, Angers University;Hospital, 4, rue Larrey, 49933 Angers, France.;Hospital, 4, rue Larrey, 49933 Angers, France. Electronic address:;debourneau@chu-angers.fr.;Cardiology Department, Angers University Hospital, 49933 Angers, France.;Department of Biological Haematology, George Pompidou European Hospital, 75015;Paris, France.;Regional Pharmacovigilance Centre, Dijon University Hospital, 21079 Dijon,;France.;Regional Pharmacovigilance Centre, George Pompidou European Hospital, 75015;Hospital, 4, rue Larrey, 49933 Angers, France; University of Angers, 49933;Angers, France; MitoVasc Laboratory, UMR CNRS 6214 Inserm 1083, 49933 Angers, |
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