The US Food and Drug Administration on Monday revoked its March emergency authorization of two malaria drugs touted by President Donald Trump as treatments for the novel coronavirus.
"FDA has determined that [chloroquine] and [hydroxychloroquine] are unlikely to be effective in treating COVID-19," an agency announcement said. In addition to not helping treat the disease, the drugs were linked to "serious cardiac adverse events and other serious side effects."
The revocation of the "Emergency Use Authorization" does not affect long-approved uses of the drugs to treat malaria, lupus, arthritis, or related diseases, the agency noted.
In mid-March, Trump had vigorously endorsed the drugs as treatments for the coronavirus, following reports from China of its use in treatment regimens and a small French study, now widely criticized, reporting success with one drug and an antibiotic. (The French study was a major basis for the FDA authorizing use of the drug on March 28, BuzzFeed News later determined through a public records release.)
In April, however, the FDA issued a warning about use of the drugs outside hospitals to treat coronavirus, noting that it could cause potentially fatal heart risks.
A recent high-profile study that connected the drug to a higher risk of death was later retracted by its authors over concerns about its data, but a series of reports in June emerged that seem to conclusively show the drugs only offer risks that override any benefits to patients. Several other studies have previously reached similar conclusions about the drug's lack of efficacy and its potential risks to patients.
COVID-19 patients taking the drug can continue to do so in a hospital setting, the revocation noted, with their doctor's approval.
The request to pull back the authorization came from the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, which submitted the original request for the drug's approval in late March. Former BARDA chief Rick Bright has stated in a whistleblower complaint that the March request came under pressure from the White House following Trump endorsing the drug.