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FDA issues emergency authorization of anti-malaria drug for coronavirus care


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The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.

The agency allowed for the drugs to be "donated to the Strategic National Stockpile 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," HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.

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Do the drugs work? In its statement, HHS said:

“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.”

While there’s limited evidence on the efficacy of chloroquine, or hydroxychloroquine, the FDA said the drugs’ benefits outweighed their risk. In its letter, the FDA encouraged randomized clinical trials that could assess the effectiveness of the drugs. It also noted that the known and potential benefits outweigh the risks.

Who can the drugs be used to treat? The authorization is limited to patients who are currently hospitalized and weigh at least 50kg, or about 110 pounds. Under the emergency use authorization, health care providers must contact their local or state health department to access the drugs.

 

 

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Houston Methodist first in the nation to be approved by FDA to transfuse donated plasma from recovered COVID-19 patient

 

 

HOUSTON – Houston Methodist Hospital will be the first academic medical center in the country to transfuse donated plasma from a recovered COVID-19 patient to a critically-ill COVID-19 patient.

"What we did is transfused COVID-19 convalescent plasma to two critically ill patients," said Dr. Eric Salazar, the principal investigator and a physician-scientist at Houston Methodist. "It's plasma that's been collected from donors that previously had COVID-19 and have successfully recovered,"

The idea is that the donated plasma may have lifesaving antibodies made by the immune system, which could help an individual fight off the disease, according to Dr. Jim Musser, the chair of the Pathology and Genomic Medicine at Houston Methodist.

Houston Methodist doctors said transferring the antibody-rich plasma into a COVID-19 patient may allow the power of the antibodies into a possible lifesaving therapy. Convalescent serum therapy is a concept that dates back centuries.

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