FDA Revokes Emergency Use Authorization of Drug Touted by Trump for Coronavirus Treatment
The Food and Drug Administration (FDA) is rescinding its Emergency Use Authorization (EUA) for the drugs hydroxychloroquine and chloroquine as a treatment for coronavirus. President Donald Trump has touted…
The Food and Drug Administration (FDA) is rescinding its Emergency Use Authorization (EUA) for the drugs hydroxychloroquine and chloroquine as a treatment for coronavirus. President Donald Trump has touted hydroxychloroquine as a potential treatment for the coronavirus.
FDA Chief Scientist Denise Hinton wrote in a letter on Monday, “We now believe that the suggested dosing regimens for as detailed in the Fact Sheets are unlikely to produce an antiviral effect.”
Hinton said, “Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of treatment in hospitalized patients with COVID19.”
“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,” Hinton added.
Additionally, she said it is “no longer reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”
As the virus began spreading in the U.S., Trump repeatedly touted what he said was the potential for the drug to be used as a treatment — despite warnings from the FDA about the drug.
During a White House press briefing on March 19, Trump mentioned the possibility that the drug could be used as a treatment.
He said, “Now, a drug called chloroquine — and some people would add to it ‘hydroxy-.’ Hydroxychloroquine. So chloroquine or hydroxychloroquine. … It is known as a malaria drug, and it’s been around for a long time and it’s very powerful.”