FDA authorizes emergency use of antimalarial drugs for COVID-19
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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.
Reference:
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.
Perspective
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Alfred H.J. Kim, MD, PhD
The intent of the FDA approval for emergency use of hydroxychloroquine and chloroquine (HCQ/CQ) is generally consistent with our recommendations, which attempts to limit HCQ/CQ usage if “no adequate, approved, and available alternative[s]” are available. Additionally, the announcement specifies that use should be limited to situations when clinical trials are not available at a particular hospital or if it may expose harm to a patient.
But the lack of specifics regarding appropriate use limit the positive intent attached with this approval.
The major caveat is that there are no appropriate use guidelines since the quality of clinical data supporting HCQ/CQ in COVID-19 is poor and heavily confounded, substantially limiting interpretative value.
The impact of the lack of guidelines for HCQ/CQ use opens up the possibility for overutilization in COVID-19 patients, such as use in any hospitalized patient or more worrisome, in prophylactic use where absolutely no data currently exist for this use.
Furthermore, without explicitly outlining these limitations of use in public statements, the public may misinterpret this emergency use approval as justification for use of HCQ/CQ as a treatment in COVID-19. This is certainly not the case.
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