Today, the FDA revoked the Emergency Use Authorization (EUA) which allowed for chloroquine and hydroxychloroquine donated to the Strategic National Stockpile (SNS) to be distributed and used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a trial was not feasible. Following a review of recent and ongoing clinical trials, along with the increased risk for potential cardiac adverse events and other potential side effects, the agency felt that the benefits of these drug for treating COVID-19 no longer outweighed the risks. Therefore, the EUA legal criteria was no longer being met.
In a separate warning, the FDA advised against the co-administration of chloroquine or hydroxychloroquine and remdesivir in patients with COVID-19. The drugs should not be given together since they can lead to reduced antiviral activity for remdesivir. The FDA’s fact sheet, which accompanies remdesivir, was also updated with this warning.
Download our "Coronavirus Disease 2019 (COVID-19) – The Search for a Treatment” Issues Document below to learn more information regarding therapies in development for COVID-19.