FDA Drug Safety Announcement Cautions Against Use of Hydroxychloroquine, Chloroquine in COVID-19

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Guidance that cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside the hospital or clinical trial setting has been issued by the U.S. Food and Drug Administration (FDA), citing reports of serious heart rhythm problems with these drugs.

The Drug Safety Communication states the FDA is aware of increased use of these medicines through outpatient prescriptions and reminds health care professionals and the public that these drugs have not been approved by the FDA for the treatment or prevention of COVID-19.

Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19 and they are being studied in clinical trials. Their only use for COVID-19 patients should be through the Emergency Use Authorization, which included fact sheets on the risks with the use of hydroxychloroquine or chloroquine.

The ACC has also cautioned against the use of hydroxychloroquine or chloroquine outside of the hospital or clinical trials, informing clinicians that they can cause QT interval prolongation and ventricular tachycardia. This risk can increase when these drugs are combined with drugs that prolong the QT interval, such as azithromycin which is also being used off label for the treatment of COVID-19. Patients with cardiovascular and renal disease are likely at increased risk from these drugs. Read the joint statement from the ACC, American Heart Association and Heart Rhythm Society and an expert analysis on the risk of ventricular arrhythmia with hydroxychloroquine-azithromycin treatment for COVID-19, all on ACC's COVID-19 Hub.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Implantable Devices, Genetic Arrhythmic Conditions, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, Novel Agents, Statins

Keywords: Coronavirus, Coronavirus Infections, Hydroxychloroquine, Chloroquine, Azithromycin, American Heart Association, Pharmaceutical Preparations, United States Food and Drug Administration, COVID-19, severe acute respiratory syndrome coronavirus 2, Arrhythmias, Cardiac, Long QT Syndrome


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