Hinton said that "it is no longer reasonable to believe that the known and potential benefits of CQ and HCQ outweigh the known and potential risks associated with the authorized use." .
Read the letter and memo regarding the revocation. Neither showed any benefit to mortality rates or in speeding recovery in a recent large randomized clinical trial of hospitalized patients.
The FDA also revised the fact sheet for healthcare providers and the fact sheet for patients and caregivers for the EUA of remdesivir for the CCP (Chinese Community Party) virus, the novel coronavirus from China that causes the COVID-19 disease.
Mere weeks ago hydroxychloroquine was being hailed as a potential game-changer in COVID-19 treatment.
"It certainly didn't hurt me", Trump replied Monday when asked by the media about the FDA's withdrawing the emergency authorization for hydroxychloroquine use. "The totality of scientific evidence now available indicate a lack of benefit", FDA said.
Speaking on which, Anand Shah, M.D, Deputy Commissioner for Medical and Scientific Affairs at U.S FDA said that the agency's decisions regarding EUA may evolve as per the updated data and considering the balance of risk against benefits for the treatment of COVID-19. "We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence", Shah said. It will remain available for its previously approved conditions, which include rheumatoid arthritis and systemic lupus erythematosus as well as malaria, and can still be prescribed off-label at physicians' discretion.
Last month, President Trump disclosed that he was taking hydroxychloroquine daily to prevent a COVID-19 infection. National Institutes of Health guidelines now recommend against use of the drugs outside of clinical trial environments.
"The ongoing WHIP COVID-19 study is an FDA-approved study looking at hydroxychloroquine as a potential preventative medication for healthy, pre-screened individuals", Dr. Steven Kalkanis, chief executive officer of the Henry Ford Medical Group, told Metro Times in a statement on Monday. Despite that risk, regulators said they have not yet seen the problem in patients.