FDA Revoked Emergency Use Approval of Hydroxychloroquine for COVID-19
FDA Revoked Emergency Use Approval of Hydroxychloroquine for COVID-19

June 15, 2020

The U.S. Food and Drug Administration announced June 15 that it revoked approval called emergency use authorization (EUA) for hydroxychloroquine and chloroquine to be used to treat certain patients who had been hospitalized for COVID-19.

The FDA made this decision based on its ongoing analysis of the scientific data from current studies and clinical trials.  The Agency “determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.” The FDA also determined that the risk did not outweigh the benefit for the use of chloroquine and hydroxychloruqine based on serious cardiac side effects that showed up in the studies of its use for COVID-19.  

“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, M.D. “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 authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

Source: FDA June 15 Press Release

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