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Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports.
Goldman, Adam; Bomze, David; Dankner, Rachel; Hod, Hanoch; Meirson, Tomer; Boursi, Ben; Maor, Elad.
  • Goldman A; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Israel.
  • Bomze D; School of Medicine, Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Dankner R; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Israel.
  • Hod H; School of Medicine, Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Meirson T; Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.
  • Boursi B; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Israel.
  • Maor E; Unit for Cardiovascular Epidemiology, The Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.
Br J Clin Pharmacol ; 87(3): 1432-1442, 2021 03.
Article in English | MEDLINE | ID: covidwho-787556
ABSTRACT

AIM:

There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine (CQ) during the coronavirus (COVID-19) pandemic. We analysed real-world data using the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) database to assess HCQ/CQ-associated cardiovascular adverse events (CVAEs) in pre-COVID-19 reports.

METHODS:

We conducted disproportionality analysis of HCQ/CQ in the FAERS database (07/2014-9/2019), using reporting odds ratio (ROR) and the lower bound of the information component 95% credibility interval (IC025 ).

RESULTS:

The full database contained 6 677 225 reports with a mean (±SD) age of 53 (±17) years and 74% females. We identified 4895 reports of HCQ/CQ related adverse events, of which 696 (14.2%) were CVAEs. Compared with the full database, HCQ/CQ use was associated with a higher reporting rate of major CVAEs, including cardiomyopathy (n = 86 [1.8%], ROR = 29.0 [23.3-35.9]), QT prolongation (n = 43 [0.9%], ROR = 4.5 [3.3-6.1]), cardiac arrhythmias (n = 117 [2.4%], ROR = 2.2 [1.8-2.7]) and heart failure (n = 136 [2.8%], ROR = 2.2 [1.9-2.7], all IC025 > 0). No statistically significant differences were observed between sex and age groups. CVAEs were reported more often in patients with systemic lupus erythematosus and Sjogren's syndrome. HCQ/CQ-associated CVAEs demonstrated subsequent hospitalization and mortality rates of 39% and 8%, respectively. Overdose reports demonstrated an increased frequency of QT prolongation and ventricular arrhythmias (35% and 25%, respectively).

CONCLUSION:

In a real-world setting, HCQ/CQ treatment is associated with higher reporting rates of various CVAEs, particularly cardiomyopathy, QT prolongation, cardiac arrhythmias and heart failure. HCQ/CQ-associated CVAEs result in high rates of severe outcomes and should be carefully considered as an off-label indication, especially for patients with cardiac disorders.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Cardiovascular Diseases / Chloroquine / Pharmacovigilance / COVID-19 Drug Treatment / Hydroxychloroquine / Antimalarials Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Br J Clin Pharmacol Year: 2021 Document Type: Article Affiliation country: Bcp.14546

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Cardiovascular Diseases / Chloroquine / Pharmacovigilance / COVID-19 Drug Treatment / Hydroxychloroquine / Antimalarials Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Br J Clin Pharmacol Year: 2021 Document Type: Article Affiliation country: Bcp.14546