FDA authorizes emergency use of antimalarial drugs for COVID-19
The FDA authorized the emergency use of two antimalarial medications to treat some hospitalized patients with COVID-19.
The agency issued an Emergency Use Authorization (EAU) allowing the use of hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be distributed and used for adolescent and adult patients with COVID-19 who have been hospitalized and who cannot be part of a clinical trial.
“The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions,” the FDA wrote.
The agency said the SNS will work with FEMA to ship donated doses of the medications to states.
President Trump was criticized recently for promoting hydroxychloroquine, which is often prescribed to treat lupus, as a potential therapy for COVID-19 without much evidence that it works and despite concerns about safety.
Hydroxychloroquine and chloroquine are being tested in an international trial launched by WHO to find potential therapies for the disease.
FDA. Emergency Use Authorization. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidtherapeutics. Accessed March 30, 2020.