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FDA revokes emergency use status of hydroxychloroquine for COVID-19

The FDA said the drugs hydroxychloroquine and chloroquine pose a greater risk to COVID-19 patients than any potential benefits.

WASHINGTON — The U.S. Food and Drug Administration is revoking its emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects. 

The drugs had been frequently promoted by President Donald Trump and he even took a two-week course of hydroxychloroquine preventatively after two White House staffers tested positive for COVID-19.

In Monday's announcement, the FDA said based on new evidence, oral formulations of hydroxychloroquine and the related drug chloroquine "are unlikely to be effective in treating COVID-19" under the emergency use authorization. 

The FDA added that "in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits" of the drugs "no longer outweigh the known and potential risks for the authorized use."

The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.

The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.

RELATED: Doctors kept close eye on President Trump while he used malaria drug

RELATED: Fauci definitively states hydroxychloroquine lacks efficacy against coronavirus

The drug proved ineffective for preventing COVID-19 in the first large, high-quality study to test it in people in close contact with someone with the disease. Results published by the New England Journal of Medicine show that hydroxychloroquine was no better than placebo pills at preventing illness from the coronavirus. The drug did not seem to cause serious harm, though -- about 40% on it had side effects, mostly mild stomach problems.

Credit: AP
FILE - This Monday, April 6, 2020 file photo shows an arrangement of hydroxychloroquine tablets in Las Vegas. According to results released on Thursday, May 7, 2020, a new study finds no evidence of benefit from a malaria drug widely promoted as a treatment for coronavirus infection. Hydroxychloroquine did not lower the risk of dying or needing a breathing tube in a comparison that involved nearly 1,400 consecutive patients treated at Columbia University Irving Medical Center in New York. (AP Photo/John Locher)