On June 15, 2020, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorization (EUA) of chloroquine and hydroxychloroquine for the treatment of COVID-19.

On March 28, 2020, the FDA issued an EUA allowing hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. The decision to revoke the EUA was based on new information, including clinical trial data results, that have led to the conclusion that chloroquine/hydroxychloroquine may not be effective to treat COVID-19, and that the potential benefits for such use do not outweigh its known and potential risks.

The FDA notes the specific reasons for the revocation as follows:

  • The FDA now believes that the suggested dosing regimens for hydroxychloroquine and chloroquine are unlikely to produce an antiviral effect.

  • Earlier observations of decreased viral shedding with hydroxychloroquine or chloroquine treatment have not been consistently replicated, and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between hydroxychloroquine and standard of care alone.

  • Current U.S. treatment guidelines do not recommend the use of chloroquine or hydroxychloroquine in hospitalized patients with COVID-19 outside of a clinical trial, and the National Institutes of Health (NIH) guidelines now recommend against such use outside of a clinical trial.

  • Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of hydroxychloroquine treatment in hospitalized patients with COVID-19.

Hydroxychloroquine that has been FDA-approved for other indications can still be distributed; however, the chloroquine products covered by the EUA are not approved by the FDA for any indication, and therefore cannot be legally introduced into interstate commerce.

Food and Drug Administration (FDA). Emergency Use Authorization revocation for chloroquine phosphate and hydroxychloroquine sulfate. June 15, 2020. Available at: click here. Accessed June 15, 2020.