Coronavirus (Covid-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

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Today, the US Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that allowed chloroquine phosphate and hydroxychloroquine to be donated to the Strategic National Stockpile for use in treating certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation was not. In a possible clinical trial. The agency has determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the US Food and Drug Administration has determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for authorized uses in the EUA. In addition, in light of ongoing serious adverse cardiac events and other potentially serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks of authorized use. This is the legal standard for the EUA version. The Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services originally requested the EUA to cover chloroquine and hydroxychloroquine, and the Food and Drug Administration granted the EUA on March 28, 2020 based on the science and data available at the time. Today, in consultation with the US Food and Drug Administration, BARDA sent a letter to the US Food and Drug Administration (FDA) requesting that the EUA be rescinded based on the latest science and data.

“We have 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 SARS-CoV-2, review the latest data, and consider the balance of risks versus medical and scientific affairs,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, Ph.D. Medicine, “Benefits of COVID-19 Therapeutics” The FDA always supports its decisions with the most reliable, high-quality, and up-to-date evidence available. We will continue to examine all emergency use authorizations issued by the FDA and make changes, as appropriate, based on emerging evidence.”

The Food and Drug Administration (FDA) is responsible for regularly reviewing the appropriateness of the EUA, and as such, the agency will review emerging information related to emergency uses of authorized products. Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population in which chloroquine and hydroxychloroquine were allowed for emergency use, showed that hydroxychloroquine showed no benefit in mortality or in accelerating recovery. This finding was consistent with other new data, including data showing that the proposed dosing regimens of chloroquine and hydroxychloroquine are unlikely to kill or prevent the virus that causes COVID-19. The total scientific evidence currently available indicates no benefit.

As additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we have determined that an emergency use authorization is no longer appropriate. “This action was taken after rigorous evaluation by scientists at our Center for Drug Evaluation and Research,” said Patricia Cavazoni, director of the FDA’s Center for Drug Evaluation and Research. “We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients with timely access to appropriate new treatments. Our decisions will always be based on an objective and accurate assessment of scientific data, and this will never change.”

Both chloroquine and hydroxychloroquine are approved by the US Food and Drug Administration to treat or prevent malaria. Hydroxychloroquine is also approved for the treatment of autoimmune diseases such as chronic discoid lupus erythematosus, adult systemic lupus erythematosus, and rheumatoid arthritis. Both drugs have been prescribed for years to help patients with these debilitating, or even fatal, illnesses, and the Food and Drug Administration has determined that these drugs are safe and effective when used for these illnesses according to FDA-approved labels. It should be noted that FDA-approved products may be prescribed by physicians for off-label uses if they determine that they are appropriate to treat their patients, including during COVID.

The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetics, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.

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