FDA Withdraws Emergency Approval of Anti-Malaria Drugs to Treat COVID-19

By Jane Farrell

The federal Food and Drug Administration (FDA) has withdrawn its emergency use authorization (EUA) of two anti-malaria drugs to treat COVID-19 patients, the agency said.

The drugs affected, chloroquine phosphate and hydroxychloroquine sulfate, are normally used to combat malaria. But under the EUA, the FDA allowed them to be used to treat some patients with COVID-19 when a clinical trial wasn’t available, or a patient’s participation in such a trial wasn’t feasible.

President Trump had praised the drugs, saying they were a potent weapon against COVID-19. The president said he had taken hydroxychloroquine sulfate to guard against the global pandemic that has caused 2.14 million cases of the virus in the United States, and 117,000 deaths.

“Our decisions will always be based on…rigorous evaluation of the scientific data.”

According to an FDA news release, the drugs were rejected by the agency because “they are unlikely to be effective in treating COVID-19.” The agency also cited “serious cardiac adverse events and other potential serious side effects” of the drugs. “The known and potential benefits of chloroquine and hydroxychloroquine,” the agency said in its statement, “no longer outweigh the known and potential risks for the [emergency] authorized use.”

The Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services, originally requested the EUA covering chloroquine and hydroxychloroquine. The FDA granted the EUA in March. But on June 15, BARDA sent a letter to the FDA requesting revocation of the EUA based on “up-to-date science and data.”

“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 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, M.D. “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.”

The FDA news release also 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.”

Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation, said that the agency remains “committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies. Our decisions will always be based on objective and rigorous evaluation of the scientific data. This will never change.”

Chloroquine and hydroxychloroquine are both FDA-approved to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. Both drugs have been prescribed for years to help patients with these debilitating, or even deadly, diseases, and FDA has determined that these drugs are safe and effective when used for these diseases in accordance with their FDA-approved labeling.