The Food and Drug Administration on Monday revoked its emergency authorization for a pair of malaria drugs that has been used to treat coronavirus patients after the regulators determined the "legal criteria for issuing an EUA are no longer met.
"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," the FDA wrote in a statement. "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."
The drugs are usually prescribed to patients with lupus or rheumatoid arthritis, but the FDA issued the emergency authorization for off-label use in late March after reports of its efficacy in treating patients diagnosed with COVID-19 in other parts of the world.
Now that the FDA has withdrawn the authorization, shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities to treat coronavirus patients.
“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.”
The drug was at one point touted by President Donald Trump as a potential treatment for the virus early on in the pandemic, and at one point, shocked many medical professionals when he revealed he had been taking the drug as a preventative measure.
Health researchers are still looking for a potential treatment for the coronavirus, which has so far killed more than 115,827 and sickened more than 2 million people in the United States alone.
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