Article ; Online: Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports.
British journal of clinical pharmacology
2020 Volume 87, Issue 3, Page(s) 1432–1442
Abstract: ... adverse events (CVAEs) in pre-COVID-19 reports.: Methods: We conducted disproportionality analysis ... Food and Drug Administration Adverse Events Reporting System (FAERS) database to assess HCQ/CQ-associated cardiovascular ... Aim: There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine ...
| 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 (IC 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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| MeSH term(s) | Adult ; Aged ; Antimalarials/adverse effects ; Antimalarials/therapeutic use ; COVID-19/complications ; COVID-19/drug therapy ; Cardiovascular Diseases/chemically induced ; Cardiovascular Diseases/epidemiology ; Chloroquine/adverse effects ; Chloroquine/therapeutic use ; Databases, Factual ; Drug Overdose ; Female ; Humans ; Hydroxychloroquine/adverse effects ; Hydroxychloroquine/therapeutic use ; Male ; Middle Aged ; Odds Ratio ; Pharmacovigilance ; Treatment Outcome |
| Chemical Substances | Antimalarials ; Hydroxychloroquine (4QWG6N8QKH) ; Chloroquine (886U3H6UFF) |
| Keywords | covid19 |
| Language | English |
| Publishing date | 2020-09-22 |
| Publishing country | England |
| Document type | Journal Article ; Observational Study |
| ZDB-ID | 188974-6 |
| ISSN | 1365-2125 ; 0306-5251 ; 0264-3774 |
| ISSN (online) | 1365-2125 |
| ISSN | 0306-5251 ; 0264-3774 |
| DOI | 10.1111/bcp.14546 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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