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Pharmacovigilance follow-up of patients in the context of the COVID-19 pandemic - 11/10/23

Doi : 10.1016/j.therap.2023.01.004 
Aurélie Grandvuillemin a, , Fanny Rocher b, Marie Blanche Valnet-Rabier c, Milou-Daniel Drici b, Anne Dautriche a

the French Pharmacovigilance Network

a Centre régional de pharmacovigilance de Bourgogne, University Hospital, 21079 Dijon, France 
b Pharmacovigilance, Department of Pharmacology, Pasteur Hospital, 06001 Nice, France 
c Regional Pharmacovigilance Center of Besançon, University Hospital, 25000 Besançon, France 

Corresponding author. Centre régional de pharmacovigilance de Bourgogne, University Hospital, 14, rue Paul-Gaffarel, 21079 Dijon cedex, Francerégional de pharmacovigilance de Bourgogne, University Hospital, 14, rue Paul-GaffarelDijon cedex21079France

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Summary

Introduction

In the context of COVID-19 pandemic, a national pharmacovigilance survey was set up in March 2020. The purpose of this survey was to ensure continuous monitoring of adverse drug reactions (ADRs) in patients with COVID-19, not only related to the drugs used in this indication but also related to all drugs administered to these patients or suspected of having promoted the infection.

Material and methods

This descriptive study was based on data extracted from the French Pharmacovigilance Database from 1 January 2020 to 30 September 2021. Misuse was also analysed through the MESANGE project. The ADRs were classified according to three groups: “drugs used to treat COVID-19”, “other drugs administered to COVID-19 positive patients” and “drugs suspected of having promoted COVID-19”. The data were also presented according to 2 periods (period one was from January to June 2020 and period two from July 2020 onwards).

Results

Among 2189 included cases, 67.1% were serious. Cases were mainly related to “other drugs administrated to COVID-19 positive patients” (58.5%) followed by “drugs used to treat COVID-19” (33.7%) and “drugs suspected of having promoted COVID-19” (7.8%). Drugs used to treat COVID-19 and their main safety profile were different depending on the period: mostly hydroxychloroquine (51%) with heart injury and lopinavir/ritonavir (42%) with liver injury for the first period, and dexamethasone (46%) with hyperglycemia and tocilizumab (28%) with liver injury for the second period. The drugs suspected of worsening COVID-19 differed in both periods especially for non-steroidal anti-inflammatory drugs mainly reported in period 1 (41.5% versus 8.2% in period 2). Other immunosuppressive drugs were in the majority in the second period (85.7%), with mainly methotrexate (15.3%), anti-CD20 (15.3%) and anti-TNF alpha (10.5%). No confirmed safety signal was identified among other drugs administered to patients with COVID-19. The profile of ADRs and suspected drugs was similar between the 2 periods. The study of misuse in outpatient settings identified in both periods mainly hydroxychloroquine, azithromycin, ivermectin and zinc±vitamin C.

Discussion

This survey, based on real-time pharmacological and medical assessment of ADRs and weekly meetings in a specific national committee, made it possible to identify relevant safety signals which contribute to patient care with no delay. The main safety signal highlighted was serious cardiac damage under hydroxychloroquine, alone or combined with azithromycin and also with lopinavir/ritonavir. This signal has contributed to the evolution of the recommendations for these 2 drugs. The methodology of this survey has been taken over and is still going on for the pharmacovigilance monitoring of vaccines against COVID-19, for monoclonal antibodies used against COVID-19 and also for Paxlovid® (nirmatrelvir/ritonavir) which benefit from dedicated surveys.

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Keywords : Pharmacovigilance survey, Drug safety, COVID-19


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© 2023  Société française de pharmacologie et de thérapeutique. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 78 - N° 5

P. 523-529 - septembre 2023 Retour au numéro
Article précédent Article précédent
  • French pharmacovigilance survey of casirivimab - imdevimab monoclonal antibodies in coronavirus disease (COVID-19)
  • Claire de Canecaude, François Montastruc, Sandrine Bergeron, Paola Sanchez-Pena, Aurélie Grandvuillemin, French Network of Regional Pharmacovigilance Centers
| Article suivant Article suivant
  • Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022
  • Kevin Bihan, Lorène Lipszyc, Florian Lemaitre, Anne Dautriche, Sophie Fédrizzi, Marina Atzenhoffer, Aurélie Vitores, Annabelle Page, Bénédicte Lebrun-Vignes

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