This week the U.S. Food and Drug Administration (FDA) updated recommendations and revoked existing emergency use authorizations concerning chloroquine, hydroxychloroquine, and other potential COVID-19 drugs.
When chloroquine and hydroxychloroquine rose to prominence as possible treatments or prophylactics against the coronavirus, the FDA issued emergency use authorizations, or EUAs, allowing physicians to begin prescribing the anti-malaria drug to patients. Now, however, the FDA is ruling the drugs are unlikely to be effective.
“In light of ongoing serious cardiac adverse events and other potential serious side effects,” the agency says in an official statement, “the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks.”
Acting director of the FDA’s Center for Drug Evaluation, Patrizia Cavazzoni, M.D., clarifies, “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… Our decisions will always be based on objective and rigorous evaluation of the scientific data. This will never change.” For more, read the FDA’s full statement.
At the same time, the FDA has updated the guidelines surrounding another EUA drug, the broad-spectrum antiviral remdesivir. A recent non-clinical laboratory study found chloroquine and hydroxychloroquine interfered with remdesivir’s antiviral effectiveness. When allowed to work, studies have shown remdesivir can shorten COVID-19 recovery times. Additional details are available in the FDA’s statement and drug fact sheet.
These updates come as the search for a dedicated vaccine continues and the FDA updates many of its EUA classifications, including reusing certain face masks.
The tightening of regulations has even extended to antibody tests. The agency began sending warning letters this week to companies it found to be inappropriately marketing tests with false or misleading claims. Explaining in a statement, Director of FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D. says, "Providing regulatory flexibility during this public health emergency never meant we would allow fraud.”
As more information emerges and experts continue to refine their recommendations, it remains clear that social distancing through steps like Telehealth, and limiting the spread of the virus, remain the best way to combat the pandemic.