There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine (CQ) during the coronavirus (COVID?19) pandemic. Researchers analyzed 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.
New research has added to the growing body of evidence that potential Covid-19 drugs hydroxychloroquine (HCQ) and chloroquine are linked to higher rates of various cardiovascular problems. The study, published in the British Journal of Clinical Pharmacology, revealed that HCQ and chloroquine were associated with life-threatening heart rhythm events, heart failure, and damage to the heart muscle itself (termed cardiomyopathy). “Moreover, we show how these adverse events carry high risks for severe outcomes including death, even with standard doses of the drugs,” said study senior author Elad Maor from the Tel-Aviv University in Israel.
For the findings, the research team analyzed real-world data from the Food and Drug Administration Adverse Events Reporting System, a global database of post-marketing safety reports. The researchers found the use of HCQ or chloroquine associated with cardiovascular problems and high rates of severe outcomes.
It should be carefully considered as an off-label indication, especially for patients with cardiac disorders, the study authors wrote. “The take-home message of our work is that physicians around the world should be careful when prescribing these drugs,” Maor noted. According to a recent study, published in the journal Lancet Rheumatology, HCQ, and azithromycin (AZM) have been linked to significant cardiovascular risks, including mortality. Last month, a study published in the journal Annals of Internal Medicine, showed that HCQ was also ineffective for Covid-19 patients with early and mild symptoms. Recently, German researchers have said that the antimalarial drug chloroquine is not able to prevent infection of human lung cells by the novel coronavirus.
Facts already known about this subject:
- Case reports and small series of hydroxychloroquine/chloroquine (HCQ/CQ) treatment found an increased frequency of conduction disorders, QT prolongation, and, rarely, the development of Torsade de Pointes, cardiomyopathy, and heart failure.
- There is limited data regarding HCQ/CQ?related cardiovascular adverse events (CVAEs) and their outcomes in a real-world population.
What the new data show:
- In a real-world setting, various CVAEs are associated with HCQ/CQ treatment, particularly cardiomyopathy, QT prolongation, cardiac arrhythmias, and heart failure.
- These adverse events carry a high risk for severe outcomes, including death, even with standard doses.
Concurrent use of furosemide, amiodarone, or warfarin was more common in QT prolongation reports, and overdosing was associated with increased frequency of QT prolongation and ventricular arrhythmias.
Adam Goldman, David Bomze, Rachel Dankner, Hanoch Hod, Tomer Meirson, Ben Boursi, and Elad Maor. Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports.