July 7,2020

A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available. This includes reports of serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure.

Based on ongoing analysis and emerging scientific data, FDA has revoked the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible. We made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery. 

This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, we determined that the legal criteria for the EUA are no longer met. Please refer to the Revocation of the EUA Letter and FAQs on the Revocation of the EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate for more information.