FDA issues emergency use authorization for hydroxychloroquine and chloroquine to treat COVID-19

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The FDA granted emergency use authorization March 28 to allow patients with COVID-19 to be treated with hydroxychloroquine and chloroquine. 

The authorization means hydroxychloroquine and chloroquine drugs donated to the strategic national stockpile will be distributed to hospitals to be used for certain COVID-19 patients. 

The authorization allows physicians to prescribe the drugs to adolescent and adult COVID-19 patients as appropriate when a clinical trial is not available or feasible. 

The authorization does not mean the drugs are approved, however. The drugs can be prescribed for COVID-19 for only as long as the pandemic lasts. 

An emergency use authorization is different from an approval, as it means a drug may be effective, while approval means there's evidence showing it is effective. There has not been enough evidence to prove that either hydroxychloroquine or chloroquine are effective in treating COVID-19, according to the FDA. 

The emergency use authorization also requires fact sheets detailing the risks of the drugs are made available to healthcare providers and patients. 

Both hydroxychloroquine and chloroquine were designed to treat malaria but are commonly used to treat autoimmune diseases such as lupus and rheumatoid arthritis.

 

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