In a major turnabout, the Food and Drug Administration said Monday that two related drugs promoted by President Trump are no longer authorized for treating coronavirus infections.
The agency revoked its authorization for the emergency use of hydroxychloroquine and chloroquine because they’re ineffective against Covid-19 and can cause serious heart-rhythm problems for those who take them.
In a statement, FDA chief scientist Denise Hinton said large clinical trials show that the drugs “are unlikely to produce an antiviral effect.”
“Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence,” Politico reports.
Scientists who conducted two randomized controlled trials, “considered the gold standard for determining whether a drug is effective,” concluded that hydroxychloroquine does not prevent coronavirus infection and does not help hospitalized patients, Politico says.
“In March, Trump said hydroxychloroquine used in combination with the antibiotic azithromycin had ‘a real chance to be one of the biggest game changers in the history of medicine,’” Reuters says — but he offered no significant evidence to back up that claim.
Trump said later that he took the drugs preventively after two people who worked at the White House contracted Covid-19.
Originally developed to fight malaria, hydroxychloroquine was found to be effective as a treatment for lupus and arthritis, so it will remain available for doctors who choose to ignore the FDA and use it “off label” for Covid-19.
