The US Food and Drug Administration (FDA) has revoked the emergency use authorisation (EUA) that allowed chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be used for COVID-10 patients.
Based on emerging scientific data, the FDA determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorised uses in the EUA. In light of serious cardiac adverse events and other potentially serious side effects, the known and potential benefits no longer outweighed the known and potential risks. The Biomedical Advanced Research and Development Authority (BARDA) requested that the FDA revoke the authorisation.
“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.
“The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorisations the FDA has issued and make changes, as appropriate, based on emerging evidence.”