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FDA revokes emergency use of hydroxychloroquine

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A pharmacy tech pours out pills of Hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020.

George Frey | AFP | Getty Images

The Food and Drug Administration said Monday it is ending its emergency use authorization of chloroquine and hydroxychloroquine, the anti-malaria drugs backed by President Donald Trump to combat Covid-19.

The agency determined the drugs were “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.”

“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 wrote in its notice Monday.

The FDA issued the emergency use of the drugs in March. The EUA meant that doctors would be allowed to use the drugs on patients hospitalized with Covid-19 even though they had not been formally approved by the agency. 

However, the FDA warned consumers a month later against taking the drugs to treat Covid-19 outside a hospital or formal clinical trial setting due to the risk of  “serious heart rhythm problems” in some patients.

Trump disclosed last month he was taking hydroxychloroquine daily to prevent infection from the coronavirus.

In addition to treating malaria, hydroxychloroquine is often used by doctors to treat rheumatoid arthritis and lupus. It is known to have serious side effects, including muscle weakness and heart arrhythmia. Numerous clinical trials are looking to see if it’s effective in fighting Covid-19, but it is not a proven treatment.

A recent study published in the New England Journal of Medicine found the drug was no better than a placebo in preventing infection of the coronavirus.

This is a developing story. Please check back for updates.

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