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 [chloroquine and hydroxychloroquine] 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 [hydrozycholoroquine] 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.”
“But the nice part is, it’s been around for a long time, so we know that if it — if things don’t go as planned, it’s not going to kill anybody,” he added.
In the days and weeks following that briefing, he regularly touted the dug.
“Hydroxychloroquine is — is a very powerful drug for certain things, and it’s a very successful drug,” Trump said on March 27.
He added, “There’s reason to believe that it could be successful here. Now, the reason I disagree with you — and I think Tony [Fauci] would disagree with me — but the reason I disagree with you is that we have a pandemic. We have people dying now.”
On March 28, the FDA issued its Emergency Use Authorization for the drugs. But the next month, the FDA warned against using hydroxychloroquine and chloroquine because it could lead to abnormal heart rhythms.
Despite warnings against using the drug, Trump revealed that he began taking hydroxychloroquine as a preventative measure, as IJR reported. Trump’s physician reported that the president was not exhibiting side effects from the drug.
