WASHINGTON - The Food and Drug Administration issued a warning Friday against using malaria drugs hydroxychloroquine and chloroquine to treat COVID-19 outside of a hospital setting or formal clinical trial.
The drugs have been widely touted by President Donald Trump as a possible treatment for the new coronavirus. However, the agency said it became aware of reports of “serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin.”
"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," the FDA said on its website.
Both drugs are in clinical trials examining their effectiveness in treating and preventing COVID-19, but the FDA said neither are proven treatments.
Patients taking the drugs for approved reasons, such as malaria or autoimmune conditions like lupus, should continue taking their medicine as prescribed, the FDA added.
Tablets of hydroxychloroquine are displayed in a file image taken on April 22, 2020. (Photo Illustration by Soumyabrata Roy/NurPhoto via Getty Images)
The agency said the drugs can still be used in hospital settings or clinical trials, but it was not immediately clear whether some planned trials in the future would be stopped after the warning.
Remdesivir, an experimental COVID-19 treatment previously used to treat Ebola patients, has also garnered massive attention as the world scrambles to contain the pandemic with a proven medicine or preventative vaccine.
But in its first randomized clinical trial in China, the drug failed to have any effect, according to reports.
More than 100 different programs have been launched to develop and test treatments for COVID-19, as well as dozens of experimental vaccines against the coronavirus, according to the World Health Organization.
This story was reported from Cincinnati.