Coronavirus Update: The Emergency Use Authorization for Hydroxychloroquine Ended by FDA

Coronavirus Update: The Emergency Use Authorization for Hydroxychloroquine Ended by FDA

The U.S. Food and Drug Administration (FDA) has ended the emergency use authorization (EUA) for a pair of drugs which President Donald J. Trump and his supporters touted as a “gamechanger” when it comes to the treatment of COVID-19.

The drugs chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ), meant for the treatment of malaria, have lost their EUA after studies revealed that that they may not be effective in fighting COVID-19 and the potential benefits of taking them for such use does not outweigh the known and potential risks, according to a letter from Rear Admiral Denise M. Hinton, chief scientist for the FDA, to a Biomedical Advanced Research and Development Authority (BARDA) official.

The reasons for the revocation include:

·      The dosage levels included in the drugs’ fact sheets are now believed to be unlikely to produce an antiviral effect

·      Previous observations of viral shedding under a HCQ and CQ regimen have not been consistently replicated and recent data shows no difference between using the drugs and standard of care alone

·      U.S. treatment guidelines do not recommend the use of the drugs outside of a clinical trial and the National Institute of Health guideline recommend against using the drugs outside of a clinical trial

·      Larger recent trials have shown no evidence of benefit for mortality or other outcomes including hospital length of stay and ventilation when the drug is used to treat COVID-19

“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 HCQ and CQ 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.

The drugs came to the forefront of the national discussion of COVID-19 as Trump repeatedly touted them and in press briefings and ordered the administration to purchase millions of doses despite a lack of testing. Trump himself claimed to be taking the drug after several White House staffers tested positive for the virus.

Trump’s words were taken to heart by his supporters as a man and his wife in Arizona ingested a form of CQ used to clean fish tanks. The move killed the man and sent his wife to the hospital.

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