FDA Revokes EUA for Chloroquine and Hydroxychloroquine

June 15, 2020

Since the emergency use authorization was granted, new data on heart risks associated with hydroxychloroquine and chloroquine have been revealed.

Shortly after the World Health Organization (WHO) suspended its hydroxychloroquine study, the FDA revoked the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate to be used in hospitalized patients with coronavirus disease 2019 (COVID-19).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” FDA said in a press release.1

The FDA is also concerned about the “ongoing serious cardiac adverse events and other potential serious side effects,” it said. “The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The FDA granted the EUA on March 28 based on the science and data available at the time. “Today, in consultation with the FDA, Biomedical Advanced Research and Development Authority (BARDA) sent a letter to the FDA requesting revocation of the EUA based on up to date science and data,” the agency said.

Since the EUA was granted, new data on heart risks associated with the medication have been revealed.

In addition, the agency said that recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. “This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.”

“The revocation of FDA’s emergency use authorization is not surprising given recent publications showing a lack of improvement on mortality or other clinical outcomes in hospitalized patients. The FDA has determined that the lack of benefit of these drugs no longer outweighs the risk of treatment. The efficacy of hydroxychloroquine or chloroquine in preventing COVID-19 after exposure is still not yet established and clinical trials are ongoing," Michael Ganio PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP) said in a statement provided to Drug Topics®.

WHO said in late May that it was temporarily pausing the hydroxychloroquine arm of its Solidarity Trial, which is evaluating the drug for use in COVID-19, as it reviews safety data.2

The suspension comes after data from the trial was published by The Lancet on May 22, which showed that treatment with hydroxychloroquine and chloroquine, with or without a macrolide, did not demonstrate in-hospital clinical benefits in patients with COVID-19. Moreover, the study authors reported an estimated higher mortality rate among patients receiving the drug, according to the findings.3

The FDA defended its original approval of hydroxychloroquine. “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 FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”