The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.

In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres.

Clinical presentation and management of drug-induced agranulocytosis.

Objective: In this article, we report and discuss the clinical presentation and management of idiosyncratic drug-induced agranulocytosis (neutrophil count <0.5 × 10(9)/l).

Results/conclusions: Idiosyncratic drug-induced agranulocytosis remains a potentially serious adverse event owing to the frequency of severe sepsis with severe deep tissue infections (e.

[Idiosyncratic drug-induced agranulocytosis].

Idiosyncratic drug-induced agranulocytosis is a potential adverse event of most drugs, rare but life-threatening. Its annual incidence does not exceed 10 cases per million population in Europe and has remained stable over the past two decades. Its pathogenesis is poorly understood.

Recognition and management of drug-induced blood cytopenias: the example of drug-induced acute neutropenia and agranulocytosis.

Background: More than several hundred drugs, toxins, and herbs have been reported to cause blood abnormalities, and drugs account for 20 - 40% of all instances of cytopenias.

Objective: In the present paper, we report and discuss the recognition and the management of drug-induced acute neutropenia or agranulocytosis (neutrophil count of < 0.5 x 10(9)/l).

Idiosyncratic drug-induced agranulocytosis: Update of an old disorder.

In this paper, we review the literature on idiosyncratic drug-induced agranulocytosis, a rare but life-threatening potential adverse event of most drugs. Articles were identified through MEDLINE searches (1966-2005). Additional references were localized through a review of textbooks on hematology and internal medicine, and information gleaned from international meetings.

Puffy hand syndrome due to drug addiction: a case-control study of the pathogenesis.

Aim: We studied the pathogenesis of puffy hand syndrome of intravenous drug use. We hypothesized that injections of high-dose sublingual buprenorphine, instead of the recommended sublingual administration, could play an important role in lymphatic obstruction and destruction.

Design And Participants: We set up a case-control study in substitution centres, recruiting intravenous drug addicts with and without puffy hands, respectively.

Modern management of non-chemotherapy drug-induced agranulocytosis: a monocentric cohort study of 90 cases and review of the literature.

BACKGROUND: The present study reports a monocentric experience of 90 drug-induced agranulocytosis cases and discusses their management, in particular the role of hematopoietic growth factors. METHODS: Data from 90 patients with drug-induced agranulocytosis who met the criteria of the IAAAS group and of Bénichou and Solal-Celigny [Nouv Rev Fr Hematol 1993; 33: 257.] were retrospectively reviewed.

Nonchemotherapy drug-induced agranulocytosis in elderly patients: the effects of granulocyte colony-stimulating factor.

Purpose: Elderly patients with nonchemotherapy drug-induced agranulocytosis present commonly with severe infections, and have a mortality of at least 20%. We studied whether granulocyte colony-stimulating factor (G-CSF), a hematopoietic growth factor that shortens the duration of neutropenia, is useful in these patients.

Subjects And Methods: We studied 54 patients > or =65 years of age who had drug-induced agranulocytosis, some of whom had been treated with G-CSF.