The agency granted emergency use authorization to the two drugs March 28 for treatment of patients with COVID-19. However, the FDA has concluded the drugs should not be prescribed outside clinical trials because research has not proven them to be an effective preventive or therapeutic treatment for the disease.
The FDA’s letter details “it is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”
The letter came as a response to the Biomedical Advanced Research and Development Authority’s request to revoke the authorizations.
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