FDA rescinds emergency use of hydroxychloroquine for COVID-19
The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized patients with the novel coronavirus (COVID-19), according to a statement released by the agency on Monday.
The agency determined that the legal criteria for issuing an EUA are no longer met, the statement said. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
Additionally, considering ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use, the agency said, noting this is standard for EUA issuance.
The Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services originally requested the EUA covering chloroquine and hydroxychloroquine, and the FDA granted the EUA on March 28 based on the science and data available at the time. On Monday, in consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on up to date science and data.
Chloroquine and hydroxychloroquine are both FDA-approved to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. Both drugs have been prescribed for years to help patients with these diseases, and FDA said it has determined that these drugs are safe and effective when used for these diseases in accordance with their FDA-approved labeling.
According to the agency, FDA approved products may be prescribed by physicians for off-label uses if they determine it is appropriate for treating their patients, including during COVID.