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Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance
Adam Goldman1,2, David Bomze1,2,3, Rachel Dankner1,4
1Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Israel.
Insights
Hydroxychloroquine (HCQ) and chloroquine (CQ) use is linked to increased cardiovascular adverse events (CVAEs), including cardiomyopathy and arrhythmias. These drugs require careful consideration, especially in patients with pre-existing heart conditions.
Area of Science:
- Pharmacovigilance
- Cardiology
- Drug Safety
Background:
- Clinical need for safety data on hydroxychloroquine (HCQ) and chloroquine (CQ) during the COVID-19 pandemic.
- Previous studies lacked comprehensive real-world safety data for HCQ/CQ, particularly concerning cardiovascular adverse events (CVAEs).
Purpose of the Study:
- To assess HCQ/CQ-associated CVAEs using real-world data from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) database.
- To evaluate the safety profile of HCQ/CQ regarding cardiovascular health in a pre-COVID-19 context.
Main Methods:
- Disproportionality analysis of HCQ/CQ in the FAERS database from July 2014 to September 2019.
- Utilized reporting odds ratio (ROR) and the lower bound of the information component (IC025) to identify significant associations.
Main Results:
- HCQ/CQ use was associated with significantly higher reporting rates of CVAEs, including cardiomyopathy, QT prolongation, cardiac arrhythmias, and heart failure.
- CVAEs led to hospitalization in 39% and mortality in 8% of cases. Overdose reports showed increased QT prolongation and ventricular arrhythmias.
- Higher CVAE rates were observed in patients with systemic lupus erythematosus and Sjogren's syndrome.
Conclusions:
- Real-world data indicate HCQ/CQ treatment is associated with increased reporting of serious CVAEs.
- The potential for severe outcomes necessitates careful consideration of HCQ/CQ, especially for patients with cardiac conditions or when used off-label.
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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