FDA revokes emergency approval of hydroxychloroquine

Medical experts globally have gone back and forth in the past months debating the efficacy of hydroxychloroquine as a coronavirus treatment

By Sophie Mann

Published: June 15, 2020 12:54pm

Updated: June 15, 2020 3:16pm

The Food and Drug Administration on Monday stripped hydroxychloroquine of its emergency-use authorization for treating coronavirus patients.

The FDA had previously issued a warning about the use of the drug outside of clinical trials and hospitals. It has been shown, in some cases, to cause dangerous heart side effects.

The drug, which was praised and taken by President Trump in March and April, may continue to be prescribed off-label by doctors, because it is approved as a treatment for malaria, lupus and rheumatoid arthritis.

FDA chief scientist Dr. Denise Hinton wrote Monday in a letter: "It is no longer reasonable to believe that oral formulations of HCQ [hydroxychloroquine] and CQ [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks."

"As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19," the letter also stated.

The FDA's emergency use-authorization applied only to hospitalized coronavirus patients and drugs donated to the Strategic National Stockpile.

In early June, medical journal The Lancet retracted a study they published that linked the drug to a higher risk of death from coronavirus.