The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed providers to use chloroquine phosphate and hydroxychloroquine sulfate to treat hospitalized patients with COVID-19 when a clinical trial was unavailable or participation in a clinical trial was not feasible, according to an agency press release.
The EUA specifically covered chloroquine and hydroxychloroquine products donated to the Strategic National Stockpile.
The decision to revoke the EUA follows a Drug Safety Communication, which the agency posted to its website in May, warning about potential side effects of the drugs, including serious and potentially life-threatening heart rhythm problems.
The FDA said it reached the conclusion “that chloroquine and hydroxychloroquine 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 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.”
Separately June 15, the FDA warned about a possible interaction between chloroquine and hydroxychloroquine and remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease.
Based on a recently completed non-clinical laboratory study, the FDA said it is revising the fact sheet for healthcare providers on remdesivir, stating that they should not co-administer remdesivir and chloroquine or hydroxychloroquine as it may result in reduced antiviral activity of remdesivir.
The FDA said it had granted the EUA on March 28 based on a request from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services (HHS) and the scientific evidence available at the time. In a similar vein, BARDA sent a letter to the FDA on June 15 asking the agency to revoke the EUA.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD.
In announcing the decision to revoke the EUA, the FDA cited the following scientific evidence:
• Results from a large randomized clinical trial in hospitalized patients demonstrated that demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery.
• Recent data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19.
• NIH guidelines that recommend against using the drugs to treat patients with COVID-19 outside of a clinical trial.
Chloroquine and hydroxychloroquine are both FDA-approved to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as lupus and rheumatoid arthritis.
