The U.S Food and Drug Administration (FDA) today "revoked the emergency use authorization" (EUA) granted on March 28 for chloroquine or hydroxychloroquine for the treatment of hospitalized patients with COVID-19 when a clinical trial was not available or participation was not feasible.

The FDA stated in a press release that the agency had determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA.

According to the press release, recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.

Read the full letter revoking the use of these drugs from the FDA to the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services, which had made both the request for the EUA and for it to be rescinded. A Frequently Asked Questions (FAQ) document also released by the FDA states the treatment course can be completed for hospitalized patients currently being treated with these drugs "to the extent found necessary by the patient's attending physician." The document also notes that clinical trials of these drugs for patients with COVID-19 will continue.

The ACC has also cautioned against the use of hydroxychloroquine or chloroquine outside of the hospital or clinical trials, informing clinicians the drugs 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, COVID-19 Hub, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Novel Agents, Statins

Keywords: Coronavirus, Coronavirus Infections, ACC Advocacy, Hydroxychloroquine, Chloroquine, Azithromycin, COVID-19, United States Food and Drug Administration, severe acute respiratory syndrome coronavirus 2, Arrhythmias, Cardiac, Tachycardia, Ventricular, United States Dept. of Health and Human Services

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