COVID-19 Thread 3/30/2020 (FDA Issues Emergency Use Authorization for Donated Hydroxychloroquine Sulfate, Chloroquine Phosphate)

There has been a lot of discussion about the use of hydrochlorquine/chloroquine as a treatment for COVID-19, and many physicians around the world have been using it in treating patients, some reporting significant success. In some countries this has had approval from health authorities, in other countries, physicians have been using it in ‘off-label’ use.

Now in the United States, a Department of Health and Human Services press release announces that the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for these drugs.

An Excerpt:

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.

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 SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states. The SNS does not regularly stock either drug.