The FDA says it has revoked emergency authorization for hydroxychloroquine and chloroquine to treat COVID-19, saying the evidence shows the recommended dose is unlikely to be effective against the virus.
George Frey/Reuters
After reviewing new information from large clinical trials the agency now believes that the suggested dosing regimens"are unlikely to produce an antiviral effect," FDA chief scientist Denise Hinton saidThe anti-malarial drugs, which also have been used to treat lupus and other conditions, aren’t being removed from the market. And the FDA says the drugs can still be prescribed by doctors for “off-label” uses if they think it’s appropriate. Clinical trials also will continue.
“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 Anand Shah, the agency’s deputy commissioner for medical and scientific affairs.about whether the drugs were effective against the virus and whether possible side effects were worth the risk.
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