ABSTRACT
Introduction: Hydroxychloroquine is an antimalarial drug that belongs to the 4-aminoquinolone group [1]. Despite of this properties presents several immunomodulatory and anti-inflammatory characteristics [1,2]. In 2020, with the emergence of the COVID-19 pandemic, researchers used existing drugs with potential for the treatment of COVID-19, including hydroxychloroquine, which ended up being used off-label [3,4]. From the clinical trials hydroxychloroquine has many adverse effects that can increase risk for the SARS-COV-2 patients health. Common adverse effects are related to gastrointestinal and cardiovascular systems, neurotoxicity and retinopathy [2,5]. Objective(s): The objective of this research was to describe the adverse effects profile of hydroxychloroquine in COVID-19 patients and to characterize the risks associated with off-label use of hydroxychloroquine. Method(s): An observational, retrospective and descriptive study was conducted. Information collected from the ''Eudravigilance'' database was analyzed using descriptive statistics with R Studio software. Information about the source of reporting, patient sex, serious adverse reactions, deaths and off-label cases and their outcome, were evaluated and compared in the pre- and post-pandemic period. Result(s): The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic period (increase of 310.3%), with health professionals (92.0%) and woman (2020: 64%;2021: 81%) reporting the most. The analysis of age groups allowed us to conclude that the 18-64 age group has the highest number of reported patients (2020: 49%;2021: 53%). The offlabel use of hydroxychloroquine was also an important aspect to consider in this study: in the period of 2020-2021, a total of 29.8% of suspected ADR have been caused by hydroxychloroquine in off-label use, with an important percentage of those being associated with COVID utilization (20.0%). Finally, deaths associated with the use of hydroxychloroquine were also evaluated, of which 67.0% are described in off-label use. Conclusion(s): The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic. The potential for harm increased as off-label administration of hydroxychloroquine was associated with an increased incidence and severity of adverse reactions. However, associated with other drugs, this drug may potentiate certain adverse reactions, such as QT interval prolongation, nausea, dizziness, hypoglycaemia, heart failure, among others. Regarding outcomes, there seems to be an increase in the number of deaths associated with hydroxychloroquine, however causality has not been established for the observed data. Hydroxychloroquine presented varied adverse reactions in the observed data, and its off-label use during the pandemic showed an increase in its incidence.
ABSTRACT
Introduction: Hydroxychloroquine is an antimalarial drug that belongs to the 4-aminoquinolone group [1]. Despite of this properties presents several immunomodulatory and anti-inflammatory characteristics [1,2]. In 2020, with the emergence of the COVID-19 pandemic, researchers used existing drugs with potential for the treatment of COVID-19, including hydroxychloroquine, which ended up being used off-label [3,4]. From the clinical trials hydroxychloroquine has many adverse effects that can increase risk for the SARS-COV-2 patients health. Common adverse effects are related to gastrointestinal and cardiovascular systems, neurotoxicity and retinopathy [2,5]. Objective: The objective of this research was to describe the adverse effects profile of hydroxychloroquine in COVID-19 patients and to characterize the risks associated with off-label use of hydroxychloroquine. Methods: An observational, retrospective and descriptive study was conducted. Information collected from the "Eudravigilance" database was analyzed using descriptive statistics with R Studio® software. Information about the source of reporting, patient sex, serious adverse reactions, deaths and off-label cases and their outcome, were evaluated and compared in the pre- and post-pandemic period. Results: The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic period (increase of 310.3%), with health professionals (92.0%) and woman (2020: 64%;2021: 81%) reporting the most. The analysis of age groups allowed us to conclude that the 18-64 age group has the highest number of reported patients (2020: 49%;2021: 53%). The offlabel use of hydroxychloroquine was also an important aspect to consider in this study: in the period of 2020-2021, a total of 29.8% of suspected ADR have been caused by hydroxychloroquine in off-label use, with an important percentage of those being associated with COVID utilization (20.0%). Finally, deaths associated with the use of hydroxychloroquine were also evaluated, of which 67.0% are described in off-label use. Conclusion: The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic. The potential for harm increased as off-label administration of hydroxychloroquine was associated with an increased incidence and severity of adverse reactions. However, associated with other drugs, this drug may potentiate certain adverse reactions, such as QT interval prolongation, nausea, dizziness, hypoglycaemia, heart failure, among others. Regarding outcomes, there seems to be an increase in the number of deaths associated with hydroxychloroquine, however causality has not been established for the observed data. Hydroxychloroquine presented varied adverse reactions in the observed data, and its off-label use during the pandemic showed an increase in its incidence.