The FDA has revoked its emergency use authorization for hydroxychloroquine and chloroquine for treatment of COVID-19 patients, according to a June 15 alert on the agency’s website.
“We made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery,” the FDA wrote.
Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19Source: FDA
The FDA said data showed the suggested dosing for these medicines “are unlikely to kill or inhibit” SARS-CoV-2. “As a result, we determined that the legal criteria for the EUA are no longer met.”
Read the EUA revocation letter here.