Hydroxychloroquine: Someone Finally Called the Mercy Rule

The scientific community kept giving hydroxychloroquine one more chance. And the highly touted drug just kept losing. As the evidence against it mounted, it failed its biggest chance yet, and the FDA finally invoked the mercy rule.

Hydroxychloroquine is an antimalarial drug that has received a lot of high profile attention as a possible treatment for COVID-19. Several hospitals have offered it, often in combination with azithromycin, to COVID-19 patients. It has long been denied that the available science supports its use (Lancet 2020;doi:doi.org/10.1016/S0140-6736(20)30817-5). But science kept giving it another chance. In the U.S., an emergency use authorization permitted the use of hydroxychloroquine and chloroquine in adults and adolescents who weigh at least 50 kg. But, the FDA has now revoked even that emergency use authorization.

Hydroxychloroquine memorandum of explanation, the FDA said that “it is unlikely that CQ [chloroquine] or HCQ [hydroxychloroquine] may be effective in treating COVID-19. Further, in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the Agency has concluded that the known and potential benefits of CQ and HCQ do not outweigh the known and potential risks for the authorized uses.

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