The Food and Drug Administration on Monday yanked its emergency use authorization for hydroxychloroquine as a treatment for the coronavirus in hospitals, citing a lack of evidence it worked and that the risks outweighed any potential benefits.
The agency said the drug, along with a similar version called chloroquine, which is normally prescribed to treat malaria and some forms of severe arthritis, was “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” according to a statement, CNBC reported.
“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 said.
The FDA authorized the emergency use of the drugs in March, and President Trump has frequently touted the drug — which he said he himself took as a preventive measure with no side effects.
Trump said at the White House later Monday that he was unaware of the FDA’s move, but that he suffered no ill effects.
“I can’t complain about it,” he said. “It certainly didn’t hurt me.”
And Health and Human Services Secretary Alex Azar said doctors could still prescribe if off-label for individual patients despite the move by the FDA, which he oversees.
The FDA order, he continued, applied only to hospital settings, not individual interactions between a doctor and patient.
“If a doctor wishes to prescribe it working with a patient they may prescribe it for any purpose they wish to do so,” he said.
The FDA said “it is no longer reasonable to believe” the drug may be effective against as a coronavirus treatment or that any potential benefits outweighed “known and potential risks.”
The move came after several studies of the drug suggested it was not effective, including a widely anticipated trial earlier this month that showed it failed to prevent infection in people who have been exposed to the virus.
With Post wires