ddrjzmu

Property	Value
?:abstract	INTRODUCTION: In the stressful context of the coronavirus disease 2019 (COVID-19) pandemic, some reports have raised concerns regarding psychiatric disorders with the use of hydroxychloroquine. In this study, we reviewed all psychiatric adverse effects with hydroxychloroquine in COVID-19 patients, as well as in other indications, reported in VigiBase, the World Health Organization\'s (WHO) global database of individual case safety reports. METHODS: First, we analyzed all psychiatric adverse effects, including suicide, of hydroxychloroquine in COVID-19 patients reported to 16 June 2020. We also performed disproportionality analysis to investigate the risk of reporting psychiatric disorders with hydroxychloroquine compared with remdesivir, tocilizumab, or lopinavir/ritonavir prescribed in COVID-19 patients. We used reporting odds ratios (RORs) and their 95% confidence intervals (CIs) to calculate disproportionality. Second, we sought to examine the psychiatric safety profile of hydroxychloroquine in other indications (before 2020). RESULTS: Among the 1754 reports with hydroxychloroquine in COVID-19 patients, we found 56 psychiatric adverse effects. Half of these adverse effects were serious, including four completed suicides, three cases of intentional self-injury, and 12 cases of psychotic disorders with hallucinations. Compared with remdesivir, tocilizumab, or lopinavir/ritonavir, the use of hydroxychloroquine was associated with an increased risk of reporting psychiatric disorders (ROR 6.27, 95% CI 2.74-14.35). Before 2020, suicide was the main cause of death among all adverse drug reactions reported with hydroxychloroquine, followed by cardiac adverse effects (cardiomyopathy) and respiratory failure. CONCLUSIONS: This pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic.
is ?:annotates of	<https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0004936> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0018524> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0033975> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0041755> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0852733> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0879626> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C0939237> <https://research.tib.eu/covid-19/entity/9ddrjzmu_hasAnnotation_C3470566>
?:creator	<https://research.tib.eu/covid-19/entity/Garcia%2C_Philippe%3B_Revet%2C_Alexis%3B_Yrondi%2C_Antoine%3B_Rousseau%2C_Vanessa%3B_Degboe%2C_Yannick%3B_Montastruc%2C_Fran%C3%A7ois>
?:journal	Drug_Saf
?:license	unk
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/9ddrjzmu_HAS_C0020336_PREDISPOSES_C0004936> <https://research.tib.eu/covid-19/entity/9ddrjzmu_HAS_C0020336_TREATS_C5203670> <https://research.tib.eu/covid-19/entity/9ddrjzmu_HAS_C0041755_PRECEDES_C0879626> <https://research.tib.eu/covid-19/entity/9ddrjzmu_HAS_C4726677_PREDISPOSES_C0004936>
?:source	WHO
?:title	Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:who_covidence_id	#880370
?:year	2020

Property

Value

?:abstract

INTRODUCTION: In the stressful context of the coronavirus disease 2019 (COVID-19) pandemic, some reports have raised concerns regarding psychiatric disorders with the use of hydroxychloroquine. In this study, we reviewed all psychiatric adverse effects with hydroxychloroquine in COVID-19 patients, as well as in other indications, reported in VigiBase, the World Health Organization\'s (WHO) global database of individual case safety reports. METHODS: First, we analyzed all psychiatric adverse effects, including suicide, of hydroxychloroquine in COVID-19 patients reported to 16 June 2020. We also performed disproportionality analysis to investigate the risk of reporting psychiatric disorders with hydroxychloroquine compared with remdesivir, tocilizumab, or lopinavir/ritonavir prescribed in COVID-19 patients. We used reporting odds ratios (RORs) and their 95% confidence intervals (CIs) to calculate disproportionality. Second, we sought to examine the psychiatric safety profile of hydroxychloroquine in other indications (before 2020). RESULTS: Among the 1754 reports with hydroxychloroquine in COVID-19 patients, we found 56 psychiatric adverse effects. Half of these adverse effects were serious, including four completed suicides, three cases of intentional self-injury, and 12 cases of psychotic disorders with hallucinations. Compared with remdesivir, tocilizumab, or lopinavir/ritonavir, the use of hydroxychloroquine was associated with an increased risk of reporting psychiatric disorders (ROR 6.27, 95% CI 2.74-14.35). Before 2020, suicide was the main cause of death among all adverse drug reactions reported with hydroxychloroquine, followed by cardiac adverse effects (cardiomyopathy) and respiratory failure. CONCLUSIONS: This pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic.

is ?:annotates of