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FDA Withdraws Authorization for Hydroxychloroquine

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June 16, 2020 -- The FDA has withdrawn its Emergency Use Authorization for the anti-malaria drug hydroxychloroquine.

The drug, also used to treat disorders such as lupus, has been touted by President Donald Trump, who later announced he took hydroxychloroquine for two weeks, with guidance from his doctor.

In its announcement, the FDA says neither hydroxychloroquine nor chloroquine phosphate have been shown to provide anti-viral protections against COVID-19.

Early signs that the drugs decreased “viral shedding” of coronavirus “have not been consistently replicated and recent data from a randomized controlled trial” showed them to have no impact.

The move to revoke the authorization for use came after a request by the Biomedical Advanced Research and Development Authority, an arm of the Department of Health and Human Services.

“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” Rear Admiral Denise Hinton, the FDA’s chief scientist, said in a letter to Gary L. Disbrow Ph.D., HHS deputy assistant secretary.

WebMD Health News Brief Reviewed by Hansa D. Bhargava, MD on June 16, 2020

Sources

FDA.gov, letter from Rear Admiral Denise Hinton, chief scientist, June 15, 2020

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