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FDA Approves Drug for COVID-19, But There’s a Bit of a Catch

AP Photo/Andrew Harnik, File

Media went crazy on President Donald Trump for talking about the possible benefits that experts were looking at in trials for hydroxychloroquine and chloroquine.

They chastised him saying he was being “too hopeful” or offering false hope.

Sounds like the Food and Drug Administration has come to the conclusion that it isn’t such a false hope after all.

According to Kron 4 News, the FDA has now issued an emergency use authorization for the two anti-malarial drugs to help treat people with the Wuhan coronavirus. However, they limited their authorization to those drugs that were supplied from the Strategic National Stockpile. Bayer and a division of Novartis — had donated the drugs to the stockpile.

Here was their announcement:

On March 28, 2020, FDA issued an EUA to allow 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. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized 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.

HHS said that “Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19.” The FDA said the benefits outweighed the risks, according to Kron4 News, and they encouraged trials.

The drugs had already been approved for other uses such as malaria and some doctors have been using it as an “off-label use” for compassionate or emergency care in the case of the Wuhan coronavirus.

New York is currently conducting trials using the drugs. France has also just officially sanctioned prescribing chloroquine to treat certain coronavirus patients, France 24 reported on Saturday, after a trial showed that 78 out of 80 patients recovered within five days, a considerably faster result than normal if they recovered at all.

The drug has to be supplied from the stockpile and the patients have to be currently hospitalized.

But that is an official step to recognizing that it has a beneficial use for the virus.

Author: Nick Arama

Source: Red State: Boom: FDA Approves Hydroxychloroquine and Chloroquine for Emergency Use for COVID-19, With Restrictions

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