On April 24, 2020, the FDA released a safety alert on hydroxychlorquine and chloroquine use for COVID‑19 due to the risk of cardiac arrhythmia. Case reports in the FDA Adverse Event Reporting System database, medical literature, and the American Association of Poison Control Centers National Poison Data System have identified serious heart-related adverse events in patients treated with these agents alone or in combination with other QT prolonging agents (eg, azithromycin). Reported heart-related adverse events include QT prolongation, ventricular tachycardia, ventricular fibrillation, and death.
The FDA cautions against use of hydroxychlorquine and chloroquine outside of a hospital setting or clinical trial. The FDA has authorized the temporary use of hydroxychlorquine or chloroquine during COVID-19 through the Emergency Use Authorization (EUA), which was based on limited evidence of the safety and efficacy of these agents. Authorized use is limited to a clinical trial with appropriate screening and monitoring or hospitalized patients who can receive careful heart monitoring. Risk of heart-related adverse events may be increased when used in combination with other medications that cause QT prolongation or in patients with comorbid health issues such as heart or kidney disease. The FDA recommends health care professionals evaluate and monitor use of hydroxychlorquine or chloroquine, which may include baseline ECG, electrolytes, renal function, or hepatic tests.
The FDA continues to review the safety and efficacy of these agents when used to treat COVID-19. Patients and health care professionals are encouraged to report side effects related to hydroxychloroquine and chloroquine via Online Reporting Form or mailing/faxing a downloaded Reporting Form.
More information is available at the following link: