The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) for hydroxychloroquine and chloroquine, previously allowed for treating certain hospitalized patients with COVID-19. This decision follows mounting evidence indicating the drugs' ineffectiveness and potential risks.
Efficacy Concerns
The FDA determined that the legal criteria for issuing an EUA were no longer met, based on ongoing analysis and emerging scientific data. The agency concluded that hydroxychloroquine and chloroquine are unlikely to be effective in treating COVID-19 for the authorized uses specified in the EUA. Earlier observations suggesting decreased viral shedding were not replicated in larger trials.
Safety Risks
In addition to efficacy concerns, the FDA highlighted the risk of serious cardiac adverse events and other potential side effects associated with hydroxychloroquine. The agency stated that the known and potential benefits of using chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use in treating COVID-19.
Clinical Evidence
Clinical data revealed no reduction in mortality, length of hospital stay, or need for mechanical ventilation in COVID-19 patients treated with hydroxychloroquine. Oxford University’s professor Martin Landray, co-leading the RECOVERY trial, stated that the drug is "useless" in treating COVID-19.
Regulatory Context
FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD, emphasized that the FDA's actions are guided by science and that decisions evolve as more is learned about the SARS-CoV-2 virus. The FDA will continue to examine all emergency use authorizations and make changes based on emerging evidence.
Global Response
Several countries, including France, Italy, and Belgium, had already moved to halt the use of hydroxychloroquine for treating COVID-19 patients, aligning with the growing consensus on its lack of efficacy and potential risks.
