FDA revokes emergency use of malaria drugs for COVID-19 patients
Monday, June 15, 2020
WASHINGTON, D.C. (WRDW/WAGT) -- The Food and Drug Administration revoked the emergency authorization to use chloroquine and hydroxychloroquine to treat certain hospitalized patients with COVID-19.
The authorization to use the malaria drugs was put into place to accommodate for use when a clinical trial was unavailable, or participation in a clinical trial was not feasible.
It was determined that the criteria for the authorization are no longer being met. Based on its ongoing analysis of the authorization and emerging scientific data,
And in light of side effects, the known and potential benefits of the drugs no longer outweigh the known and potential risks for the authorized use.
The Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services originally requested the authorization, and the FDA granted it March 28, based on the science and data available at the time.
But BARDA sent a letter to the FDA requesting revocation of the authorization based on up-to-date science and data.