US Food and Drug Administration revoked its Emergency Use Authority on Monday From hydroxychloroquine Treat COVID-19, but soon came under fire from US President Donald Trump, who said only American agencies failed to understand its benefits in fighting coronaviruses.
Based on new evidence, the FDA stated that it was no longer reasonable to believe that hydroxychloroquine and the related drug chloroquine could be effective in treating novel coronavirus-caused illness.
The FDA also warned that drugs have been shown in lab studies to interfere with Gilead Sciences Inc.’s antiviral drug remediesvir – the only one yet to show benefit against COVID-19 in formal clinical trials It is a medicine.
The move comes after several studies of decades-old malaria pills stated that they were not effective as a treatment or to prevent COVID-19.
A major trial was halted after British scientists decided earlier this month that hydroxychloroquine was “useless” in treating COVID-19 patients.
The anti-inflammatory and antiviral properties of hydroxychloroquine suggested that it might help COVID-19 patients, and the FDA authorized its emergency use in March at the height of an epidemic for which there were no approved treatments.
Initial enthusiasm was partly based on laboratory experiments in which the drug appeared to neutralize the virus. Chloroquine, which has not been approved for any use in the United States and has more side effects, has not performed any better in human clinical trials.
In March, Trump said that hydroxychloroquine in combination with the antibiotic azithromycin had “a real chance of being one of the biggest game changers in the history of the drug”, with little evidence to support this claim.
He later said that he immediately stopped the drugs after diagnosing two people working at the White House with COVID-19, and urged others to try it.
“I took it and I felt good about taking it. I don’t know if it had any effect, but it didn’t hurt me,” Trump said on Monday.
Trump said there were “great reports” from France, Spain and other places, with no evidence or further explanation. France is one of the countries that has already stopped using the drug for COVID-19 patients.
US Health and Human Services Secretary Alex Azar said the drug is being studied for possible use in the first phase of the disease.
“A lot of the figures that have come out were more negative, people who were quite ill in hospital,” he said.
The drug can still be used with a prescription, Azar said. Any drug with US approval can be used in any way the doctor sees fit, regardless of its use.
Use Already in Drug Online
In recent weeks, doctors had already pulled back on the use of hydroxychloroquine for COVID-19, after several studies suggested that it was not effective and could pose a cardiovascular risk for some patients.
The Infectious Diseases Society of America on Monday supported the FDA’s decision “to revoke the Emergency Use Authority for hydroxychloroquine and chloroquine.”
Half of the hospitals that responded to the mid-May survey conducted by the American Society of Health-System Pharmacists (ASHP) reported excess supplies of hydroxychloroquine, which they expected to return to wholesalers.
Current US government treatment guidelines do not recommend its use outside of clinical trials for COVID-19 patients.
France, Italy and Belgium last month stopped using hydroxychloroquine for COVID-19 patients. But the United States sent 2 million doses to Brazil last month, which has emerged as the epidemic’s latest epicenter.
Hundreds of trials are still underway in hydroxychloroquine or chloroquine testing as an intervention for COVID-19, designed to show that hydroxychloroquine in combination with azromromycin prevents hospitalization and death from COVID-19 Can.
(Except for the headline, this story has not been edited by NDTV staff and published from a syndicated feed.)