RA-COVID-19 V17 - Recherche - Action Coronavirus disease 2019 - Vague 17

Early identification of risk associated with drugs used in COVID-19: analysis of global pharmacovigilance data – Vigi-Drugs COVID-19

Vigi-Drugs COVID-19

Early Identification of Drug Risk in COVID-19: Analysis of Global Pharmacovigilance Data

Issues and objectives

This project aims to investigate and characterise early the major adverse drug reactions of drugs used and/or approved for the treatment of patients with Covid19. <br /> The analyses are based on the WHO global pharmacovigilance database: VigiBase® containing more than 27 million adverse drug reactions, from 160 countries and covering more than 90% of the world's population. <br /> The aim of the investigation is to select and evaluate the most frequent and clinically and pharmacologically relevant adverse drug reactions. <br /> These medicines could be prescribed to a large number of patients without specific determination of the associated risks. The need to assess the safety profile of these drugs in real-life use in Covid-19 patients is therefore paramount. <br /> This project will help to provide essential information for clinical practice and help to better manage and monitor patients treated with COVID-19 drugs.<br /><br />Translated with www.DeepL.com/Translator (free version)

The analyses are based on the WHO global pharmacovigilance database VigiBase® containing more than 27 million adverse drug reactions from 160 countries and covering more than 90% of the world's population.
The analyses are based on the WHO global pharmacovigilance database: VigiBase® containing more than 27 million adverse drug reactions from 160 countries and covering more than 90% of the world's population.
The aim of the investigation is to select and evaluate the most frequent and clinically and pharmacologically relevant adverse drug reactions.
These medicines could be prescribed to a large number of patients without specific determination of the associated risks. The need to assess the safety profile of these drugs in real-life use in Covid-19 patients is therefore paramount.
This project will help to provide essential information for clinical practice and help to better manage and monitor patients treated with COVID-19 drugs.

Translated with www.DeepL.com/Translator (free version)

Several projects have resulted in several publications
- risk assessment (hepatic, renal, cardiac) with remdesivir
- psychiatric risk assessment with hydroxychloroquine
- risk assessment with covid 19 vaccines: arterial hypertension, myocarditis, risks in adolescents, thrombosis
- a social pharmacology article was also produced

Continued work on the pharmacovigilance of covid vaccines and on the risks associated with COVID drugs (antibodies, nirmatrelvir, etc.). work is also being carried out on the quality of adverse reaction reports in clinical trials of COVID-19 drugs.

1. François Montastruc, Samuel Thuriot, Geneviève Durrieu Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019. Clin Gastroenterol Hepatol. 2020;18:2835-2836.
2. Anthony Touafchia, Haleh Bagheri, Didier Carrié, Geneviève Durrieu, Agnès Sommet, Laurent Chouchana, François Montastruc Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns Clin Microbiol Infect 2021;27(5):791.e5-791.e8. doi: 10.1016/j.cmi.2021.02.013.
3. Laurent Chouchana, Laure-Hélène Preta, Mylène Tisseyre, Benjamin Terrier, Jean-Marc Treluyer, François Montastruc Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case-noncase study. Kidney Int 2021;99(5):1235-1236
4. Philippe Garcia, Alexis Revet, Antoine Yrondi, Vanessa Rousseau, Yannick Degboe, François Montastruc Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study Drug Saf. 2020 ; 43(12):1315-1322.
5. Béatrice Bouhanick, François Montastruc, Samuel Tessier, Clara Brusq, Vanina Bongard, Jean-Michel Senard, Jean-Louis Montastruc & Fabrice Herin. Hypertension and Covid-19 vaccines: are there any differences between the different vaccines? A safety signal. European Journal of Clinical Pharmacology, 1-2.
6. Thomas Geeraerts, François Montastruc, Fabrice Bonneville, Vincent Mémier, Nicolas Raposo, Toulouse Vitt Study Group Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: A missed opportunity for a rapid return of experience Anaesth Crit Care Pain Med. 2021 May 24;40(4):100889
7. Valérie Gras-Champel, Sophie Liabeuf, Mariette Baud, Jean-François Albucher, Mehdi Benkebil, Charlène Boulay, Anthony Bron, Antoine El Kaddissi, Sophie Gautier, Thomas Geeraerts, Marie Girot, Aurélie Grandvuillemin, Hugo Laujin, Annie-Pierre Jonville-Bera, Kamel Masmoudi, Evelyne Massardier, Joëlle Micallef, Céline Mounier, François Montastruc, Antoine Pariente, Justine Perez, Nicolas Raposo, Francesco Salvo, Marie-Blanche Valnet-Rabier, Thierry Vial, Nathalie Massy, French Network of Pharmacovigilance Centres Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: Data from the French Network of Regional Pharmacovigilance Centres Therapie. 2021S0040-5957(21)00130-X. doi: 10.1016/j.therap.2021.05.007.
8. Jean-Louis Montastruc, Margaux Lafaurie, Claire de Canecaude, François Montastruc, Haleh Bagheri, Geneviève Durrieu, Agnès Sommet. COVID-19 vaccines : a perspective from a social pharmacology. Therapie. 2021 ;76(4) :311-5.
9. Déborah Foltran, Clément Delmas, Clara Flumian, Pierre De Paoli, Francesco Salvo, Sophie Gautier, Milou-Daniel Drici, Clément Karsenty, François Montastruc. Myocarditis and Pericarditis in Adolescents after First and Second doses of mRNA COVID-19 Vaccines. Soumis (2021)
10. François Montastruc, Fabrice Muscari, Ivan Tack, Justine Benevent, Margaux Lafaurie, Claire de Canecaude, Haleh Bagheri, Fabien Despas, Christine Damase-Michel, Geneviève Durrieu, Agnès Sommet. Teaching Pharmacovigilance to French Medical Students during the Covid-19 Pandemic: Interest of Distance Learning Clinical Reasoning Sessions. Soumis (2021)

In the context of the COVID-19 health emergency, several drugs are currently being tested or used for the treatment of COVID-19 patients. While there are some data to evaluate the efficacy of drugs (from clinical trials), there are no specific data on the risks associated with the drugs prescribed in the treatment of covid-19. In the VigiDrugs COVID-19 project, we will review and characterize main adverse effects with the drugs used and/or approved in the treatment of COVID-19 patients in France.
To assess the risks with COVID-19 drugs, we will conduct a weekly analysis of the WHO global pharmacovigilance database VigiBase®. VigiBase® contained more than 22 million spontaneously generated adverse drug reactions, from 136 countries and covering more than 90% of the world’s population. All reports with drugs of interest (for example remdesivir, dexamethasone, tocilizumab, lopinavir/ritonavir…) will be screened to exclude those not related to a COVID-19 indication. We will select and evaluate the most frequent and the most clinically relevant adverse drug reactions reported in VigiBase. In order to complete our pharmacovigilance review, we will perform disproportionality analyses to compare reports of adverse drug reaction of interest in COVID-19 patients exposed to one drug with those reported in COVID-19 patients exposed to other drugs used for COVD-19. This approach has already made it possible to identify several risks with the COVID-19 drugs used in France. In May 2020, we alerted about the potential risk of psychiatric disorders (including suicide) with the use of hydroxychloroquine for COVID-19 (publication in Drug Safety 2020). In July 2020, we published the first descriptions of hepatic disorders with remdesivir (Clin Gastroenterol Hepatol 2020). We want to improve our approach by using best statistical approaches that will take into account confounding factors and by speeding up analyses. Several other risks need to be assessed with these drugs. For example, risks of kidney failure or rhythm disturbances with remdesivir need to be explored.

Project coordinator

Monsieur François Montastruc (Direction de la Recherche)

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partner

DRI Direction de la Recherche

Help of the ANR 65,520 euros
Beginning and duration of the scientific project: February 2021 - 12 Months

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