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June 15, 2020, 11:55 a.m. EDT

FDA revokes authorization for hydroxychloroquine

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By Jaimy Lee

The Food and Drug Administration (FDA) said Monday that it has withdrawn the emergency use authorization (EUA) granted to hydroxychloroquine and chloroquine during the COVID-19 pandemic. An EUA is not the same as a FDA approval but is a type of authorization that can be awarded during public health emergencies when there are no other available treatment options. The federal agency had issued the EUA in March, allowing some patients with COVID-19 to be treated with the drugs when used from a federal stockpile. Since then, however, the drugs have become increasingly politicized following promotion from Trump administration officials, including President Donald Trump himself, and have faced questions about their clinical usefulness and potential safety risks. A number of clinical trials evaluating the drugs have failed, and the emerging scientific consensus has indicated that the drugs, which are approved to treat lupus, malaria, and rheumatoid arthritis, do not benefit patients with COVID-19 and may cause additional health risks. The messaging around hydroxychloroquine has been further complicated by an inaccurate study that found the drugs harmed patients. That research was later retracted by The Lancet, a prestigious medical journal. The letter revoking the EUA is addressed to an official at the Biomedical Advanced Research and Development Authority.

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