0000000000567923

AUTHOR

Marie-blanche Valnet-rabier

showing 2 related works from this author

French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge.

2021

International audience; In this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related …

MaleEuropean levelCOVID-19 VaccinesCoronavirus disease 2019 (COVID-19)Adverse drug reactions030226 pharmacology & pharmacyArticleADR adverse drug reaction03 medical and health sciencesPharmacovigilance0302 clinical medicinePharmacovigilancePandemicMedicineAdverse Drug Reaction Reporting SystemsHumansPharmacology (medical)Drug reactionPEG polyethylene glycolEntire populationVaccinesbusiness.industrySOC system organ classSARS-CoV-2COVID coronavirus disease[SCCO.NEUR]Cognitive science/Neuroscience[SCCO.NEUR] Cognitive science/NeuroscienceAuthorizationCOVID-19Middle Agedmedicine.diseaseRPVC Regional Pharmacovigilance CenterVaccinationEMA European Medicines AgencyFemaleMedical emergencyFrancebusinessANSM Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)OrganizationTherapie
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Risk of scleroderma according to the type of immune checkpoint inhibitors

2020

Abstract Introduction Immune checkpoint inhibitors (ICIs) are associated with immune-related adverse events (irAEs). Among them, ICIs-induced systemic sclerosis (SSc) is poorly known. Methods To better characterize this irAE, our comprehensive approach combined the description of ICIs-induced scleroderma cases, the systematic review of the literature and the analysis of VigiBase, the WHO pharmacovigilance database. Results We identified two cases with underlying limited cutaneous SSc who presented a dramatic increase in the skin thickening following pembrolizumab, associated with scleroderma renal crisis in one case. In the literature, four cases of scleroderma and four cases of morphea hav…

Riskmedicine.medical_specialtyScleroderma SystemicDurvalumabintegumentary systembusiness.industryImmunologyScleroderma Renal CrisisIpilimumabPembrolizumabmedicine.diseaseDermatologySclerodermaAntineoplastic Agents ImmunologicalAtezolizumabNeoplasmsmedicineHumansImmunology and AllergyNivolumabskin and connective tissue diseasesbusinessMorpheamedicine.drugAutoimmunity Reviews
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