FDA revokes emergency use of hydroxychloroquine for COVID-19
The FDA is revoking the emergency approval for the use of hydroxychloroquine to treat COVID-19.
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A Anti-malaria drug President Donald Trump, touted as treatment for COVID-19, has scored another goal, this time from the United States Food and Drug Administration. A letter from FDA chief scientist Denise Hinton announced Monday that the agency is revoking the emergency use of oral formulations of hydroxychloroquine and chloroquine to treat the coronavirus-related disease.
The FDA warned in April not to use hydroxychloroquine or chloroquine for COVID-19 outside of a hospital setting or clinical trial. The new directive is a more definitive closing of the door for the treatment of coronavirus patients.
The letter was in response to a request from Gary Disbrow, Acting Director of the Biomedical Advanced Research and Development Authority (BARDA), a government group tasked with developing countermeasures for medical threats, including pandemics.
“Today’s withdrawal request is based on new information, including data from clinical trials that led BARDA to conclude that this drug may not be effective in the treatment of COVID-19 [Coronavirus Disease 2019] and that the potential benefits of the drug for such use do not outweigh the known and potential risks, “Hinton wrote in the letter.
The FDA originally issued emergency approval for hydroxychloroquine and chloroquine in late March. The withdrawal also addresses serious concerns about the potential for cardiac side effects.
Hydroxychloroquine has been both investigated and politicized as medical professionals look for ways to treat COVID-19. The The World Health Organization has suspended clinical trials the drug in May of the same month Trump said he took it as a preventive measure.
“We will continue to use all of the FDA’s emergency approvals and may make changes based on emerging evidence,” said FDA’s Anand Shah in a statement Monday.
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