US regulator gives anti-malaria drugs emergency approval to treat coronavirus

[Pakistani Fighter]

US regulator gives anti-malaria drugs emergency approval to treat coronavirus
Issued on: 30/03/2020 - 08:35Modified: 30/03/2020 - 08:35

Nivaquine, left, which contains chloroquine, and Plaqueril, which contain hydroxychloroquine. The FDA has approved the use of these drugs in hospitals for certain cases of COVID-19 infection in teens and adults. © Gerard Julien, AFP (file photo)
Text by:NEWS WIRES
A limited emergency-use authorization for two antimalarial drugs touted as game-changers by President Donald Trump has been issued by the US Food and Drug Administration to treat coronavirus patients.

ADVERTISING
In a statement published Sunday, the US Department of Health and Human Services detailed recent donations of medicine to a national stockpile – including chloroquine and hydroxychloroquine, both being investigated as potential COVID-19 treatments.

It said the FDA had allowed them "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."

Trump said last week that the two drugs could be a "gift from God," despite scientists warning against the dangers of overhyping unproven treatments.


Donald J. Trump

✔@realDonaldTrump
https://twitter.com/realDonaldTrump/status/1241367239900778501

HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....


388K
7:13 PM - Mar 21, 2020
Twitter Ads info and privacy

174K people are talking about this



Many researchers including Anthony Fauci, the United States' leading infectious disease expert, have urged the public to remain cautious until larger clinical trials validate smaller studies.


Two US medical bodies – the National Institutes of Health and the Biomedical Advanced Research and Development Authority – are currently working to plan such trials.

Some in the scientific community fear Trump's endorsement of the medicines could create shortages for patients who need them to treat lupus and rheumatoid arthritis, diseases for which they are approved.

The US has more than 140,000 novel coronavirus cases and 2,489 deaths, according to a tracker maintained by Johns Hopkins University.

(AFP)

 

[Pakistani Fighter]

US FDA issues limited emergency use authorization for two drugs usually used to treat malaria

From CNN Health’s Arman Azad

Gerard Julien/AFP/Getty Images


The US Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine to treat patients hospitalized with Covid-19.

The drugs -- which are used to treat malaria and other conditions -- have been called game changers by President Donald Trump.

But thus far, there is little scientific evidence that chloroquine, or its closely-related analogue hydroxychloroquine, are effective in treating Covid-19.

What happened? The authorization came in a letter dated Saturday, but the US Department of Health and Human Services (HHS) acknowledged the FDA’s action in a Sunday news release. The FDA limited the scope of its authorization to drugs supplied from the Strategic National Stockpile. The HHS announced that two pharmaceutical companies -- Bayer and a division of Novartis -- had donated the drugs to the stockpile.

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.

 

[rott]

So they didn't find a cure but this is for the emergency?

 

[Taimoor Khan]

The FDA has moved mountains - Thank You!

LOL

This has been administrated to the patients in Pakistan and China for months!

After so much bickering they finally come to their sense. FDA has done jack! This was already known, so many lives could have been saved have they acted swiftly.

 

[Hack-Hook]

honestly , the drug help reduce the chance of white long but its no treatment . wonder why they didn't allowed the use of it earlier . from the beginning it was always part of treatment here . at first combination of Oseltamivir and Hydroxy Choloroquine Sulphat , then Hydroxy Choloroquine sulphat alone and in some case combined with Kaltera