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Law360 (June 15, 2020, 9:44 PM EDT ) The U.S. Food and Drug Administration on Monday took back an emergency decision allowing hospital patients to use certain malaria medicines for COVID-19, warning that they're probably not effective against it and may even interfere with a coronavirus drug sold by Gilead Sciences Inc.
In one announcement on Monday, the FDA said it was revoking its emergency use authorization that allowed hospitalized COVID-19 patients not enrolled in clinical trials to use hydroxychloroquine and chloroquine, which President Donald Trump has touted without evidence as a "game changer."
The agency said new research revealed that the drugs "are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA," adding that "the totality of scientific evidence currently available indicate a lack of benefit."
In a separate announcement Monday, the FDA said that a non-clinical study revealed that administering the two drugs along with Gilead's remdesivir "may result in reduced antiviral activity of remdesivir." The agency said it "is not aware of instances of this reduced activity occurring in the clinical setting."
Monday's announcements came less than two months after the FDA warned patients and caregivers that hydroxychloroquine and chloroquine have been linked to life-threatening heart rhythm problems. The agency on Monday reiterated that hydroxychloroquine and chloroquine have been connected to "ongoing serious cardiac adverse events and other potential serious side effects."
Since the FDA granted the emergency use authorization, however, researchers have reported that patients treated with the drugs have died at a higher rate than those receiving regular treatment.
Trump has touted hydroxychloroquine for months despite it not being proven safe or effective in COVID-19 patients, and he even claimed not long ago to have taken the drug as a prophylactic. Trump's constant hyping of hydroxychloroquine has fueled speculation that the FDA acted to appease the president.
According to press pool reports, Trump said Monday that he took hydroxychloroquine and that it hadn't hurt him. He also deflected a question to U.S. Department of Health and Human Services Secretary Alex Azar, who said that hydroxychloroquine can be used in hospitals or in the home if a doctor prescribes it, according to a pool report.
Rick Bright, former director of HHS' Biomedical Advanced Research and Development Authority, told Congress last month that the government forced him out for challenging the use of chloroquine and hydroxychloroquine for COVID-19.
Bright's removal on April 20 came the same day a national study was released suggesting that hydroxychloroquine treatment at veterans hospitals didn't help treat COVID-19 and in fact was associated with more deaths than standard care. Other studies have also found little if any benefit.
A representative for Gilead did not immediately respond to a request for comment Monday evening.
--Additional reporting by Jeff Overley, Kevin Stawicki and Mike Curley. Editing by Adam LoBelia.
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