COVID-19: FDA Revoked EUA for Hydroxychloroquine

June 16, 2020

The FDA revoked the emergency use authorization that allowed the malaria drug to be used to treat hospitalized patients with COVID-19.

The US Food and Drug Administration (FDA) announced today that it revoked the emergency use authorization (EUA) that allowed chloroquine and hydroxychloroquine to be used to treat certain hospitalized patients with coronavirus disease 2019 (COVID-19) when a clinical trial was unavailable or participation in a clinical trial was not feasible.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, in a press release.

The FDA granted the EUA on March 28, 2020 based on the information available at the time, but an increasingly conclusive body of research has shown in recent weeks hydroxychloroquine was not effective at treating COVID-19 or at preventing COVID-19 from developing in exposed patients.

These results were consistent with other new data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit SARS-CoV-2, the virus that causes COVID-19. The entirety of currently available evidence indicate a lack of benefit, the agency concluded.

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation in the same press release.

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