Food And Drug Administration Rescinds Emergency Approval For Use Of Hydroxychloroquine To Treat COVID-19

President Trump has long touted the drug as a 'game-changer' in the fight against the coronavirus.

tablets in a blister of Plaquinol (Hydroxychloroquine) are displayed on April 10, 2020 in Rio de Janeiro, Brazil
Buda Mendes / Getty Images

President Trump has long touted the drug as a 'game-changer' in the fight against the coronavirus.

The Food and Drug Administration (FDA) has revoked its authorization of the use of hydroxychloroquine as an emergency treatment for COVID-19, the illness caused by the novel coronavirus.

As CNBC reported, back in March, the agency enacted an Emergency Use Authorization (EUA) that allowed doctors to prescribe the anti-malaria drugs hydroxychloroquine and its cousin, chloroquine, off-label, to treat COVID-19. An EUA allows doctors to prescribe a drug that is not fully approved to prevent or treat an illness that has no approved treatment.

However, after 3 months of having been approved for off-label use, the FDA has withdrawn that approval, citing its lack of efficacy.

“[The drugs are] unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency said.

Further, the agency noted that side-effects associated with the drug make it too risky to use in treating COVID-19.

“Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [chlorquine] and [hydroxychloroqine] no longer outweigh the known and potential risks for the authorized use,” the agency said.

At the beginning of the COVID-19 pandemic, the medical community began looking at any and all possible treatments to fight the coronavirus. One treatment was the anti-malarial drug, sometimes in combination with an antibiotic (antibiotics target bacteria, not viruses, but in some cases, their mechanisms can be useful in treating viral illnesses).

RIO DE JANEIRO, BRAZIL - APRIL 10: In this photo illustration, a box and tablets on a blister pack of Plaquinol (Hydroxychloroquine) are displayed on April 10, 2020 in Rio de Janeiro, Brazil. Controversial hydroxychloroquine is being suggested as a potential medication that could treat the Coronavirus pandemic in Brazil. According to the Ministry of health, as of today, Brazil has 19,638 confirmed cases infected with coronavirus (COVID-19) an at least 1057 recorded fatalities. (Photo illustration by Buda Mendes/Getty Images)
  Buda Mendes / Getty Images

However, any evidence that hydroxychloroquine was effective was largely anecdotal, rather than being backed up by scientific studies.

Indeed, multiple subsequent scientific studies carried out under the same rigorous conditions that govern all drug trials — such as double-blind studies with a control group given a placebo — failed to show any evidence that the drug would be effective in treating the fatal illness.

As Stat News reported earlier in June, a major study that was wrapping up at the time seemed to close the door on whether or not the drug can be used to treat COVID-19.

“Today’s preliminary results from the RECOVERY trial are quite clear – hydroxychloroquine does not reduce the risk of death among hospitalized patients with this new disease,” University of Oxford epidemiologist Martin Landray said.

Dr. Anthony Fauci, the United States’ top infectious-disease specialist, has been similarly bearish about the drug’s utility in treating the disease. As previously reported by The Inquisitr, back in late May, he called the drug “ineffective,” citing a study in medical journal The Lancet.