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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.
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