The Food and Drug Administration (FDA) has issued a safety alert regarding the use of hydroxychloroquine and chloroquine, either alone or in combination with azithromycin, for the treatment of coronavirus disease 2019 (COVID-19).

In a statement, the Agency is warning the public that the use of these agents should be limited to clinical trial settings or for treating certain hospitalized patients under the Emergency Use Authorization (EUA). The decision to limit use was based on cases of cardiovascular complications associated with these drugs, including QT interval prolongation, ventricular tachycardia, and ventricular fibrillation reported to the FDA Adverse Event Reporting System database. These adverse events were reported from both hospital and outpatient settings and in some cases resulted in death. Patients with cardiovascular or renal disease may be especially at risk for developing these complications.

To help mitigate the risk in patients receiving these drugs in clinical trials or under the EUA, the FDA is recommending initial evaluation and monitoring of all patients, including baseline ECG, electrolytes, and renal and hepatic function testing. In addition, clinicians should be aware of the potential effects of hydroxychloroquine and chloroquine on certain patient populations. For example, patients with renal insufficiency or failure may be at increased risk of QT prolongation. In addition, the drugs can cause an increase in insulin levels that may potentially lead to severe hypoglycemia. Moreover, due to their long half-lives (~30-60 days), these agents may continue to interact with other drugs that cause QT prolongation.

“We understand that healthcare professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” said FDA Commissioner Stephen M. Hahn, MD. “The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”

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Currently, there are no approved treatments for COVID-19, however, several investigational therapies are in the works. Recently, the National Institutes of Health released recommendations compiled from available evidence and expert opinion on the management of COVID-19 to help clinicians working on the frontlines. 

For more information visit fda.gov.