Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study.
Adenosine Monophosphate
/ adverse effects
Adult
Aged
Aged, 80 and over
Alanine
/ adverse effects
Antibodies, Monoclonal, Humanized
/ adverse effects
Antiviral Agents
/ adverse effects
Databases, Pharmaceutical
Drug Combinations
Female
Hallucinations
/ chemically induced
Humans
Hydroxychloroquine
/ adverse effects
Lopinavir
/ adverse effects
Male
Mental Disorders
/ chemically induced
Middle Aged
Psychoses, Substance-Induced
/ epidemiology
Ritonavir
/ adverse effects
Self-Injurious Behavior
/ chemically induced
Suicide
/ statistics & numerical data
Suicide, Attempted
/ statistics & numerical data
Young Adult
COVID-19 Drug Treatment
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
accepted:
30
09
2020
pubmed:
21
10
2020
medline:
15
12
2020
entrez:
20
10
2020
Statut:
ppublish
Résumé
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. 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). 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. 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.
Identifiants
pubmed: 33078372
doi: 10.1007/s40264-020-01013-3
pii: 10.1007/s40264-020-01013-3
pmc: PMC7571787
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antiviral Agents
0
Drug Combinations
0
lopinavir-ritonavir drug combination
0
Lopinavir
2494G1JF75
remdesivir
3QKI37EEHE
Adenosine Monophosphate
415SHH325A
Hydroxychloroquine
4QWG6N8QKH
tocilizumab
I031V2H011
Ritonavir
O3J8G9O825
Alanine
OF5P57N2ZX
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1315-1322Références
Gunnell D, Appleby L, Arensman E, Hawton K, John A, Kapur N, et al. Suicide risk and prevention during the COVID-19 pandemic. Lancet Psychiatry. 2020;7:468–71.
doi: 10.1016/S2215-0366(20)30171-1
Kawohl W, Nordt C. COVID-19, unemployment, and suicide. Lancet Psychiatry. 2020;7:389–90.
doi: 10.1016/S2215-0366(20)30141-3
Reger MA, Stanley IH, Joiner TE. Suicide mortality and coronavirus disease 2019: a perfect storm? JAMA Psychiatry. 2020. https://doi.org/10.1001/jamapsychiatry.2020.1060 .
doi: 10.1001/jamapsychiatry.2020.1060
pubmed: 32275300
pmcid: 32275300
Cloroquina/Hidroxicloroquina: precauciones y vigilancia de posibles reacciones adversas en pacientes con COVID-19. Agencia Española de Medicamentos y Productos Sanitarios. 2020. https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/2020-seguridad-1/cloroquina-hidroxicloroquina-precauciones-y-vigilancia-de-posibles-reacciones-adversas-en-pacientes-con-covid-19/ . Accessed 25 June 2020
Médicaments utilisés chez les patients atteints du COVID-19 : une surveillance renforcée des effets indésirables—Point d’information (actualisé le 14/05/2020)—ANSM: Agence nationale de sécurité du médicament et des produits de santé. https://ansm.sante.fr/S-informer/Actualite/Medicaments-utilises-chez-les-patients-atteints-du-COVID-19-une-surveillance-renforcee-des-effets-indesirables-Point-d-information-actualise-le-14-05-2020 . Accessed 25 Jun 2020
de Ribeiro NPO, de Schier ARM, Ornelas AC, de Oliveira CM, Nardi AE, Silva AC. Anxiety, depression and suicidal ideation in patients with rheumatoid arthritis in use of methotrexate, hydroxychloroquine, leflunomide and biological drugs. Compr Psychiatry. 2013;54:1185–9.
doi: 10.1016/j.comppsych.2013.05.010
Gonzalez-Nieto JA, Costa-Juan E. Psychiatric symptoms induced by hydroxychloroquine. Lupus. 2015;24:339–40.
doi: 10.1177/0961203314558863
Good MI, Shader RI. Behavioral toxicity and equivocal suicide associated with chloroquine and its derivatives. Am J Psychiatry. 1977;134:798–601.
doi: 10.1176/ajp.134.7.798
Manzo C, Gareri P, Castagna A. Psychomotor agitation following treatment with hydroxychloroquine. Drug Saf Case Rep. 2017;4:6.
doi: 10.1007/s40800-017-0048-x
Das P, Rai A, Chopra A, Philbrick K. Psychosis likely induced by hydroxychloroquine in a patient with chronic Q fever: a case report and clinically relevant review of pharmacology. Psychosomatics. 2014;55:409–13.
doi: 10.1016/j.psym.2013.06.017
Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J. 2008;42:409–19.
doi: 10.1177/009286150804200501
UMC | VigiBase. https://www.who-umc.org/vigibase/vigibase/ . Accessed 4 Mar 2020
MedDRA MSSO Welcome. https://www.meddramsso.com/ . Accessed 4 June 2013
Brown EG, Wood L. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109–17.
doi: 10.2165/00002018-199920020-00002
Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic treatments for coronavirus disease 2019 (COVID-19): a review. JAMA. 2020;323(18):1824–36.
pubmed: 32282022
pmcid: 32282022
Faillie J-L. Case-non-case studies: principle, methods, bias and interpretation. Therapie. 2019;74:225–32.
doi: 10.1016/j.therap.2019.01.006
Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf. 2007;30:891–8.
doi: 10.2165/00002018-200730100-00007
Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13:519–23.
doi: 10.1002/pds.1001
Fiolet T, Guihur A, Rebeaud M, Mulot M, Peiffer-Smadja N, Mahamat-Saleh Y. Effect of hydroxychloroquine with or without azithromycin on the mortality of COVID-19 patients: a systematic review and meta-analysis. Clin Microbiol Infect. 2020. https://doi.org/10.1016/j.cmi.2020.08.02 (Epub 26 Aug 2020).
doi: 10.1016/j.cmi.2020.08.02
pubmed: 33166647
pmcid: 33166647
Gérard A, Romani S, Fresse A, Viard D, Parassol N, Granvuillemin A, et al. “Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: a survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers. Therapie. 2020;75:371–9.
doi: 10.1016/j.therap.2020.05.002
Drew J. Concerning the side effects of antimalarial drugs used in the extended treatment of rheumatic disease. Med J Aus. 1962;618–20.
Mascolo A, Berrino PM, Gareri P, Castagna A, Capuano A, Manzo C, et al. Neuropsychiatric clinical manifestations in elderly patients treated with hydroxychloroquine: a review article. Inflammopharmacology. 2018;26:1141–9.
doi: 10.1007/s10787-018-0498-5
Ferraro V, Mantoux F, Denis K, Lay-Macagno M-A, Ortonne J-P, Lacour J-P. Hallucinations during treatment with hydrochloroquine. Ann Dermatol Venereol. 2004;131:471–3 (in French).
doi: 10.1016/S0151-9638(04)93642-3
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497–506.
doi: 10.1016/S0140-6736(20)30183-5
Aronson JK. Case reports as evidence in pharmacovigilance. Mann’s pharmacovigilance. New York: Wiley; 2014. p. 121–37.
doi: 10.1002/9781118820186.ch10
Aronson JK. Post-marketing drug withdrawals: pharmacovigilance success, regulatory problems. Therapie. 2017;72:555–61.
doi: 10.1016/j.therap.2017.02.005
Center for Drug Evaluation and Research. FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. FDA. 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or . Accessed 25 June 2020
de Boissieu P, Kanagaratnam L, Abou Taam M, Roux M-P, Dramé M, Trenque T. Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database. Pharmacoepidemiol Drug Saf. 2014;23:989–92.
doi: 10.1002/pds.3622