JUN 18, 2020 8:29 AM PDT

FDA Cancels Emergency Approval for Hydroxychloroquine

WRITTEN BY: Annie Lennon

The US Food and Drug Administration (FDA) has decided to cancel emergency use authorization for Hydroxychloroquine and Chloroquine. The news follows results from a new study showing that Hydroxychloroquine is ineffective in preventing infections by COVID-19.

The FDA initially gave the drugs emergency use authorization in March after preliminary studies demonstrated their potential to treat COVID-19. Prescriptions for the drugs skyrocketed by almost 2000% after President Donald Trump announced them to be possible treatments for the coronavirus in March. 

The FDA's recent decision to cancel the drugs' emergency approval comes after the results of the first randomized, placebo-controlled trial studying Hydroxychloroquine. Examining its effects in 821 people across the US and Canada after exposure to the virus, the study found that the drug worked no better than a placebo in preventing COVID-19 infections. 

Due to these findings, and results of some other studies, the FDA said in a notice that the Hydrocholoquine and Chloroquine are 'unlikely to be effective' against the coronavirus. 

"Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use," the FDA continued in their statement

Due to the most recent study, the World Health Organization has also decided to drop Hydrochloroquine from its global study of potential treatments for COVID-19.

Aside from treating malaria, Hyrdrochloroquine is also used to treat rheumatoid arthritis and lupus. Although some studies are still underway on its ability to treat COVID-19, research until now has created a growing consensus that it is ineffective. 

Currently, the FDA has not approved any drugs to treat the coronavirus. The agency did, however, give Remdesivir emergency use authorization on May 1st, 2020. This came after promising results from clinical trials showing it capable of reducing recovery times from 15 to 11 days. 

 

Sources: CNBCFDAThe New England Journal of Medicine 

About the Author
University College London
Annie Lennon is a writer whose work also appears in Medical News Today, Psych Central, Psychology Today, and other outlets. When she's not writing, she is COO of Xeurix, an HR startup that assesses jobfit from gamified workplace simulations.
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