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FDA pulls emergency authorization for Trump’s favorite coronavirus drug

Published Jun 16th, 2020 10:52AM EDT

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  • Hydroxychloroquine use in coronavirus treatment is no longer authorized, the FDA announced.
  • The agency said the anti-malarial drug can only be used in clinical trials, citing recent study as clear evidence that hydroxychloroquine can not cure COVID-19 and can’t prevent the coronavirus infection.
  • The drug can still be prescribed off-label for COVID-19, and it can be used to treat malaria and rheumatoid arthritis.

Hydroxychloroquine is the most controversial coronavirus therapy of the year, mostly because Trump endorsed the unproven drug before studies had been completed. In mid-March, the president relied on early data from studies that did not meet standards for clinical trials. The drug, which is safe to use against malaria and rheumatoid arthritis, received emergency use approval from the US Food and Drug Administration (FDA) for COVID-19 therapies.

A number of studies that appeared in the last few weeks provided evidence that hydroxychloroquine isn’t effective at blocking the virus, and can’t prevent infection with COVID-19. One of the studies prompted governments and the World Health Organization to pause testing, but those trials were resumed after the study was retracted. Compared to mid-March, there’s now enough data to suggest that hydroxychloroquine isn’t a viable therapy in COVID-19, and the FDA has announced that it’s pulling the emergency use authorization.

It’s unreasonable to believe that hydroxychloroquine and chloroquine “may be effective in diagnosing, treating or preventing” the illness, the FDA wrote in a letter. As a result, the federal government will not ship hydroxychloroquine and chloroquine to state and local health authorities from the National Stockpile. In mid-April, Trump announced his administration deployed some 29 million doses from the stockpile.

According to USA Today, the FDA also warned on Monday about possible interactions between the drugs and remdesivir, which is the only antiviral drug that has shown effectiveness against COVID-19 in clinical trials. Remdesivir also received an emergency use authorization from the FDA for the treatment of COVID-19.

Hydroxychloroquine and chloroquine are still available for their standard uses, and doctors can still use them for COVID-19 via off-label prescriptions. A study has shown that hydroxychloroquine prescriptions skyrocketed in mid-March, following Trump’s endorsement.

The president said in mid-May he was on a hydroxychloroquine regimen after two West Wing staffers were infected. He also said he would take the drug again in the future. Since then, a couple of trials have shown that the drug can’t prevent infection with the novel coronavirus, as was previously hoped.

Other countries still use hydroxychloroquine in COVID-19 therapies and clinical trials, and the drug can be used in the US for the same purpose. USA Today notes that a National Institutes of Health expert panel revised its guidelines on Thursday, recommending against the use of the drug in COVID-19 therapies, except for studies.

Chris Smith Senior Writer

Chris Smith has been covering consumer electronics ever since the iPhone revolutionized the industry in 2008. When he’s not writing about the most recent tech news for BGR, he brings his entertainment expertise to Marvel’s Cinematic Universe and other blockbuster franchises.

Outside of work, you’ll catch him streaming almost every new movie and TV show release as soon as it's available.