FDA Revokes EUA for Hydroxychloroquine and Chloroquine for COVID-19
The FDA revoked the emergency use authorization (EUA) that allowed for hydroxychloroquine sulfate and chloroquine phosphate (when donated to the Strategic National Stockpile) to be used to treat hospitalized patients with COVID-19.
Based on ongoing analysis and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
Furthermore, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of these drugs no longer outweigh the known and potential risks.
Because the FDA has determined that hydroxychloroquine and chloroquine are no longer suitable for the treatment of COVID-19, injured worker patients currently undergoing a regimen of hydroxychloroquine or chloroquine may need to discontinue use of these drugs.
Currently there are no proven treatments for COVID-19 and no vaccine is available.
FDA Warns of Potential Drug Interaction That May Reduce Effectiveness of Remdisivir
The FDA is warning healthcare providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
Remdesivir is an investigational antiviral medication that has shown promise in potentially treating COVID-19, enough so that it received an emergency use authorization (EUA) from the FDA to treat COVID-19.
Hydroxychloroquine and chloroquine medications were initially given EUAs as well for the treatment of COVID-19, but those EUAs have since been revoked. Because no FDA-approved COVID-19 medications or vaccines currently exist, health providers have been using medications that have shown anecdotal promise so far.
For this reason, it is understandable, given the severity of this pandemic, why some providers may have prescribed or administered remdesivir and hydroxychloroquine or chloroquine, as all these drugs were thought to potentially help patients with COVID-19. However, it is now clear that COVID-19 patients should not mix these drugs.