FDA rescinds EUA for hydroxychloroquine for COVID-19 patients
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The FDA has rescinded the emergency use authorization, or EUA, for hydroxychloroquine for the treatment of COVID-19, according to a letter from RADM Denise Hinton, the FDA’s Chief Scientist.
According to the letter, authorization has been revoked because the drug is “unlikely to produce an antiviral effect” and because decreased viral shedding has not been consistently replicated. In addition, current treatment guidelines in the U.S. do not recommend the use of this agent for hospitalized patients with COVID-19 outside of a clinical trial; NIH guidelines also recommend against use of the drug outside of clinical trials.
Furthermore, data from a recent trial suggest no benefit for mortality in patients with COVID-19. The aforementioned trial was later retracted because of concerns regarding the validity of the data.
The drug’s initial authorization drew mixed reactions from experts, who cited concerns about shortages of the drug due to a surge in demand.
“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of [hydroxychloroquine sulfate] and [chloroquine phosphate] 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,” Hinton wrote.
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