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FDA issues emergency authorization of 2 anti-malaria drugs for coronavirus treatment
KRON4 ^ | Mar 29, 2020 - 07:08 PM PDT | CNN

Posted on 03/29/2020 9:06:53 PM PDT by snarkytart

(CNN) — 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.


TOPICS: Extended News; Front Page News; News/Current Events
KEYWORDS: bayer; chloroquine; coronavirus; covid19; fdahcq; hydrochloroquine; novartis; sandoz
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To: dadfly

Proof we really don’t need the FDA and CDC. Get rid of them and save the taxpayers some money.


21 posted on 03/29/2020 9:48:37 PM PDT by dfwgator (Endut! Hoch Hech!)
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To: Ranxerox
They are not without their issues - heart arrhythmias, for one.

Prolongation of QT is very rare with these drugs - particularly hydroxychloroquine.

22 posted on 03/29/2020 9:50:52 PM PDT by politicket (Don't remove a Bernie Sanders bumper sticker. It's the only thing holding the car together!)
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To: dfwgator

we certainly don’t need what? 2 or 300,000 of them.


23 posted on 03/29/2020 9:51:04 PM PDT by dadfly
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To: dadfly
looks like the lumbering behemoths of bureaucracy are slowly shaking themselves awake

No. They certainly didn't do it to themselves. I suspect some deranged Orange man has been manhandling them - shaken bureaucracy syndrome.

24 posted on 03/29/2020 9:51:09 PM PDT by AndyJackson
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To: dadfly

Well it would be a start.


25 posted on 03/29/2020 9:51:42 PM PDT by dfwgator (Endut! Hoch Hech!)
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To: Ranxerox

They give it to people who travel to Africa as a preventative drug.


26 posted on 03/29/2020 9:53:47 PM PDT by bray (Pray for President Trump)
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To: snarkytart
Remember how the media kept pushing Remdesivir as a possibility?

That is a scary, scary drug - and nowhere near as effective as hydroxychloroquine.

I'd rather take something that just stops the virus replicase than taking Remdesivir that messes big time with the replicated RNA strand as it's being assembled. Voodoo...

27 posted on 03/29/2020 9:54:00 PM PDT by politicket (Don't remove a Bernie Sanders bumper sticker. It's the only thing holding the car together!)
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To: snarkytart

Last week and this week I baked bread made with tonic water with quinine for my family. I thought—why not? If there is any tonic water left on the shelves, it’s time for some Gin and Tonics all around. . .


28 posted on 03/29/2020 9:55:06 PM PDT by olivia3boys
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To: snarkytart

All of a sudden the idiots at CNN are wannabe scientists. Journalists are NOT SCIENTISTS!

But in an effort to help these struggling journalists become scientists, I suggest they contract Covid-19, then they can do an in depth scientific study of their parents and grandparents dying.


29 posted on 03/29/2020 9:56:57 PM PDT by Herakles (Diversity is applied Marxism!)
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To: snarkytart

Wait...Trump was right? Again???


30 posted on 03/29/2020 9:57:29 PM PDT by moehoward
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To: AndyJackson

lol. i had a sudden vision of an bright orange mahout (with a bad comb-over) with a hitting a stubborn bull elephant with a very big stick.

hut, hut, hut...


31 posted on 03/29/2020 10:00:15 PM PDT by dadfly
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To: snarkytart

Here is the FDA Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Therapeutics

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.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidtherapeutics


32 posted on 03/29/2020 10:07:01 PM PDT by FreedomPoster (Islam delenda est)
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To: snarkytart
In its letter, the FDA encouraged randomized clinical trials that could assess the effectiveness of the drugs.

It would certainly be appropriate to conduct some trials that would establish once and for all whether this drug is effective against Covid-19. I hope some protocols have already been approved by IRBs and that patients are being enrolled.

33 posted on 03/29/2020 10:08:05 PM PDT by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org)
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To: FreedomPoster
PTL and thank you, POTUS.
34 posted on 03/29/2020 10:08:18 PM PDT by Jane Long (Praise God, from whom ALL blessings flow.)
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To: snarkytart

There isn’t time for the usual death dealing delays of beaurocratic red tape that can take decades or more. This time there are to many lives at stake.


35 posted on 03/29/2020 10:08:44 PM PDT by fella
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To: snarkytart

Little scientific evidence....
Lying bastards.

CC


36 posted on 03/29/2020 10:12:51 PM PDT by Celtic Conservative (My cats are more amusing than 200 channels worth of TV)
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To: politicket

Yes, but remdesivir is still under patent.

$$$$$$$$$$$$$$$$$$$$$$$$$

CC


37 posted on 03/29/2020 10:17:08 PM PDT by Celtic Conservative (My cats are more amusing than 200 channels worth of TV)
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To: Eagles6

The numbers look about right from what I’ve seen.

I had seen 650,000 tested yesterday.


38 posted on 03/29/2020 10:17:46 PM PDT by DannyTN
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To: bray

Same reason we are not all wearing masks - we dont have enough for everybody


39 posted on 03/29/2020 10:22:17 PM PDT by CharlesWayneCT
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To: RummyChick; bray

These problems caused by hydoxichloroquine are from long term use by RA, Lupus, and malaria patients..... taking it for months/years.

Not likely — at all — with a 5 day course.


40 posted on 03/29/2020 10:25:09 PM PDT by Jackson Brown (Accomplished without a barrier.)
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