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Sunday, December 22, 2024

FDA approves emergency use of anti-malaria drugs for COVID-19

Us azar alex podium

Health and Human Services Secretary Alex Azar

Health and Human Services Secretary Alex Azar

The Food and Drug Administration (FDA) gave emergency use authorization for two anti-malaria drugs to be used as a possible treatment for COVID-19, but Michigan Gov. Gretchen Whitmer's administration disagrees with this decision.

Hydroxychloroquine sulfate and chloroquine phosphate, two anti-malaria drugs, were issued for emergency use by the FDA to help treat the new coronavirus, The Center Square reported. 

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19,” FDA Chief Scientist Denise Hinton said in her letter approving the use of the drugs. “When used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products.”

But the Michigan Department of Licensing and Regulatory Affairs (LARA) threatened "administrative action" for any doctors in the state that prescribe either of the two drugs "without a legitimate medical purpose," The Center Square reported. 

Using the two drugs for COVID-19 could result in a shortage, which means they wouldn't be available for previously proven uses, like lupus or rheumatoid arthritis. 

Two studies testing the drugs showed that using them provided COVID-19 patients improvement, but this didn't prove them to be efficient. 

“[H]ydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin," one of the studies said, according to The Center Square.

Whitmer reaffirmed the LARA letter when asked about it.  “We want to ensure that doctors have the ability to prescribe these medicines,” Whitmer told reporters. “We also want to make sure that people who have prescriptions that predated COVID-19 have access to the medications that they need.”

The LARA letter also had a combined statement from the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists. 

“Stockpiling these medications -- or depleting supplies with excessive, anticipatory orders -- can have grave consequences for patients with conditions such as lupus or rheumatoid arthritis, if the drugs are not available in the community,” the associations said in the letter. “The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential.”

Alex Azar, Health and Human Services Secretary, said President Donald Trump is taking the necessary steps to help protect Americans. 

“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” Azar said in a statement, according to The Center Square. “We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”

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