The U.S. Food and Drug Administration on Monday revoked the emergency use authorisation for malaria drug hydroxychloroquine (HCQ) as a treatment for COVID-19. The FDA said it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the related drug chloroquine may be effective in treating the respiratory illness caused by the novel coronavirus.
The FDA determined that the drugs do not meet "the statutory criteria" for emergency use authorization.
"Based on its ongoing analysis of the emergency use authorisation (EUA) and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA. The Biomedical Advanced Research and Development," the CNN quoted FDA chief scientist Denise Hinton as saying.
The move comes after several studies of hydroxychloroquine suggested it was not effective, including a widely anticipated trial earlier this month showed it failed to prevent infection in people who have been exposed to the virus, Reuters reported.
Earlier, U.S. President Donald Trump had championed the use of the drugs for COVID-19. He said hydroxychloroquine used in combination with the antibiotic azithromycin had "a real chance to be one of the biggest game changers in the history of medicine."