The Food and Drug Administration (FDA) is warning the public not to use hydroxychloroquine or chloroquine to treat COVID-19 outside of a hospital setting or a clinical trial.
“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19,” the FDA said in a statement on Friday. President Donald Trump had previously touted hydroxychloroquine as a possible treatment.
The agency noted there have been reports of serious heart rhythm problems in patients with COVID-19 who were treated with either of the two FDA- approved drugs, which are used to treat or prevent malaria. The FDA also said it has reviewed case reports concerning serious heart-related adverse events and death in patients who received the drugs that were reported in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System.
“We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available,” the agency said.