FDA advises caution in off-label use of antimalarial drugs to treat COVID-19

April 27, 2020

The Food and Drug Administration (FDA) issued a Drug Safety Communication about the side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19.

“These risks, which are in the drug labels for their approved uses, may be mitigated when healthcare professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19,” the agency said in a statement.

In its Drug Safety Communication, the FDA said, “Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.”

The FDA issued an EUA to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be distributed and used in limited circumstances, such as for certain hospitalized patients with COVID-19 when a clinical trial is not available or feasible. The EUA requires that fact sheets with important information about using these drugs in treating COVID-19, including the known risks and drug interactions, as well as appropriate screening and monitoring, be made available to healthcare providers and patients.

Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.

Clinical trials are underway to determine if these drugs can benefit patients with COVID-19 or if they can prevent COVID-19 among healthcare workers, first responders or people who have been in close contact with someone with COVID-19.

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