FDA reiterates need for caution in antimalarial treatments’ off-label use for treating COVID-19

The Food and Drug Administration April 24 reminded health care providers of the need to closely monitor patients for serious and potentially life-threatening side effects of hydroxychloroquine and chloroquine when used off-label to treat COVID-19. In a Drug Safety Communication, FDA warned “adverse events were reported from the hospital and outpatient settings for treating or preventing COVID-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death.” FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.