FDA Cautions Against Use of Hydroxychloroquine or Chloroquine for COVID-19 Outside Of the Hospital Setting

In a safety communication posted on Friday, the FDA warned consumers against taking malaria drugs chloroquine and hydroxychloroquine to treat COVID-19 outside a hospital or formal clinical trial setting. The updated guidance comes after reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines.

“We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. FDA will continue to investigate risks associated with the use of hydroxychloroquine and chloroquinefor COVID-19 and communicate publicly when we have more information,” according to the FDA communication.

The FDA previously authorized the temporary use of hydroxychloroquine or chloroquine during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA).

To read the updated guidance in its entirety, click here.