1. Comparative study of the adverse event profile of hydroxychloroquine before and during the Sars-CoV2 pandemic
- Author
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Pauline Lory, Jeffrey Lombardi, Clémence Lacroix, Paola Sanchez-Pena, Serena Romani, and Aurélie Grandvuillemin
- Subjects
SOC, system organ classes ,ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ,SARS-CoV-2, severe acute respiratory syndrome coronavirus 2 ,SD, standard deviations ,WHO, World Health Organization ,Pharmacovigilance ,MedDRA, Medical Dictionary for Regulatory Activities ,SOCm, modified organ classes ,MA, marketing authorisation ,Humans ,ANSM, French Health Agency ,Pharmacology (medical) ,Pandemics ,RPVC, French regional pharmacovigilance centres ,COVID-19, coronavirus disease 2019 ,ADRs, adverse drug reactions ,SARS-CoV-2 ,MERS-CoV, Middle East respiratory syndrome coronavirus ,HCQ, hydroxychloroquine ,Adverse reaction ,COVID-19 Drug Treatment ,HIV, human immunodeficiency virus ,Long QT Syndrome ,CT, clinical trial ,RNA, Viral ,MSSO, Maintenance and Support Services Organization ,HEADING: Pharmacovigilance ,PT, preferred term ,Hydroxychloroquine - Abstract
Aims: At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, there were no clinically-tested medications for the effective treatment of coronavirus disease. In this context, on 5 March 2020, the French Public Health Council issued several recommendations for the therapeutic management of this new disease, including the use of hydroxychloroquine (HCQ). An unexpected cardiovascular safety signal was quickly identified as being more frequent than expected thanks to the reports of adverse drug reactions (ADRs) submitted to French regional pharmacovigilance centres (RPVC). The objective: of this study was to compare all ADRs reported with HCQ used in its usual indication, collected before the pandemic period (1985 to 31 December, 2019) with those reported with the coronavirus disease 2019 (COVID-19) indication (1 January to 21 July, 2020). Methods: For this purpose, reports were extracted from the French pharmacovigilance database and analysed for these two periods. Results: Our study showed a different safety profile in COVID-19 patients with more cardiac disorders (57% of ADRs versus 5% before the pandemic period), especially QT interval prolongation, resulting from an interaction with azithromycin in more than 20% of cases. Hepatobiliary disorders were also significantly more frequent. Conclusions: These observations could be associated with the effect of the virus itself on the various organs, the profile of the patients treated, and concomitant drug treatments.
- Published
- 2021