The FDA said it had determined the “potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The Food and Drug Administration on Monday announced it was revoking emergency authorization of two malaria drugs touted by President Trump as a possible “‘game changer”’ in the fight against COVID-19, saying they are “unlikely to be effective.”
The drugs, hydroxychloroquine and chloroquine, were championed by the president after a handful of questionable studies showed they might be effective in treating COVID-19. The FDA responded by authorizing emergency use of the drugs in March, allowing them to be used for hospitalized patients and during clinical drug trials.
In the months since the drugs received those authorizations, numerous studies have been published showing they have little-to-no benefit and could even increase the risk of death among COVID-19 patients. Citing these studies, the FDA issued a warning against the drug in May, warning of severe side effects, including heart rhythm problems, severely low blood pressure, and muscle or nerve damage.
In withdrawing its emergency authorization, the agency said it had finally determined the drugs “are unlikely to be effective in treating COVID-19” and that the “potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
“We determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation, said in a statement. “We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies.’
The agency’s announcement comes just weeks after President Trump revealed he himself took hydroxychloroquine as a preventative measure, despite no evidence of its efficacy as a prophylactic.
“I think it gives you an additional level of safety,” Trump said, ignoring warnings about the drug’s dangers. In defending his decision to take the drug, Trump derided one of the studies highlighting the drug’s side effects as a “Trump enemy statement” and falsely claimed that it “doesn’t hurt people.”
Trump’s repeated embrace of hydroxychloroquine led to shortages of the drug, which proved devastating to lupus patients, who rely on the drug to prevent lupus flares and reduce the severity of their symptoms, which include fatigue, joint pain, rash, and fever.
More tragically, an Arizona man died after taking the wrong form of chloroquine because he heard Trump boast about the drugs on television.
The president has yet to issue a public statement on the FDA’s decision.