The move comes after several studies of the decades-old malaria pills suggested they were not effective either as a treatment for or to prevent COVID-19
WASHINGTON| On Monday the US Food and Drug Administration revoked its emergency use authorization for hydroxychloroquine to treat COVID-19, but quickly came under fire from US President Donald Trump, who said only US agencies have failed to grasp its benefit in fighting the coronavirus.
Based on new evidence, the FDA said it was no longer reasonable to believe that hydroxychloroquine and the related drug chloroquine may be effective in treating the illness caused by the novel coronavirus.
The FDA also warned that the drugs have been shown in lab studies to interfere with Gilead Sciences Inc’s antiviral drug remdesivir the only medicines so far to show a benefit against COVID-19 in formal clinical trials.
The move comes after several studies of the decades-old malaria pills suggested they were not effective either as a treatment for or to prevent COVID-19.
British scientists earlier this month halted a large trail after deciding that hydroxychloroquine was “useless” at treating COVID-19 patients.
Hydroxychloroquine’s anti-inflammatory and antiviral properties suggested it might help COVID-19 patients, and the FDA authorized its emergency use in March at the height of a pandemic for which there were no approved treatments.
The early enthusiasm was partly based on laboratory experiments in which the drug appeared to neutralize the virus. Chloroquine, which is not approved for any use in the United States and has more side effects, has not fared any better in human clinical trials.
In March, Trump said hydroxychloroquine in combination with the antibiotic azithromycin had “a real chance to be one of the biggest game-changers in the history of medicine,” with little evidence to back up that claim. Trump also said he took the drugs preventively after two people who worked at the White House were diagnosed with COVID-19, and he urged others to try it.
Trump said on Monday, “I took it and I felt good about taking it. I don’t know if it had an impact, but it certainly didn’t hurt me.”
Trump said there had been “great reports” out of France, Spain and other places, without offering any evidence or further explanation. France is one of the countries that has already stopped using the drug for COVID-19 patients.
US secretary of Health and Human Services Alex Azar said the drug is still being studied for possible use at an earlier stage of the disease. He said, “A lot of the data that has come out that was more negative was people who were quite ill in the hospital.”
The drug can still be used with a doctor’s prescription, Azar noted. Any drug with U.S. approval can be used in any way a doctor sees fit regardless of what it has been approved for.
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