FDA revokes emergency use authorization for chloroquine, hydroxychloroquine

The U.S. Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) for chloroquine and hydroxychloroquine donated to the Strategic National Stockpile to treat certain hospitalized coronavirus patients, according to a new statement.

The FDA decided the legal criteria for issuing an EUA were “no longer met.”

Further, the FDA determined, based on ongoing analysis of the EUA and emerging scientific data, that the two drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. While the drugs are deemed generally safe when prescribed for patients with malaria or an autoimmune disease, little was otherwise known about the potential effects they had in COVID-19 patients.

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“In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use,” according to an FDA press release issued on Monday.

The FDA had granted the EUA on March 28 based on available science and data at the time. On Monday, June 15, the Biomedical Advanced Research and Development Authority (BARDA), in consultation with the FDA, sent a letter to the FDA requesting revocation of the EUA based on current information.

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“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,” Dr. Anand Shah, FDA deputy commissioner for Medical and Scientific Affairs, wrote in the statement.

“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,” Shah said.

“The totality of scientific evidence currently available indicate a lack of benefit,” according to the FDA statement.

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Fox News' Alexandria Hein contributed to this report.