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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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1 posted on 03/29/2020 9:06:53 PM PDT by snarkytart
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To: snarkytart

oops remove mine please..duplicate


2 posted on 03/29/2020 9:07:51 PM PDT by snarkytart
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To: snarkytart

It is not.

I was challenged on the source.

Keep your up, please.


3 posted on 03/29/2020 9:10:06 PM PDT by cba123 ( Toi la nguoi My. Toi bay gio o Viet Nam.)
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To: cba123

yours is under the breaking news on the side...first article.

:-)


4 posted on 03/29/2020 9:13:50 PM PDT by snarkytart
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To: snarkytart

Why limited to only the drugs from the stockpile? Won’t that delay treatment while the drugs are sent out?

Why limted to only current hospital patients. New hospital patients out of luck?

Why limited to patients weighing at least 110 pounds? Don’t want no short people round here?


5 posted on 03/29/2020 9:14:27 PM PDT by DannyTN
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To: DannyTN

It seems to me that if you test positive and showing symptoms, you should get the drug. Not wait until the patient needs hospitalization.


6 posted on 03/29/2020 9:18:55 PM PDT by virgil (The evil that men do lives after them)
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To: virgil

Agreed. I think if you test positive you should get the drug.


7 posted on 03/29/2020 9:20:25 PM PDT by DannyTN
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To: snarkytart

Wow thanks.

Thanks mod, or Jim.

:)


8 posted on 03/29/2020 9:22:58 PM PDT by cba123 ( Toi la nguoi My. Toi bay gio o Viet Nam.)
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To: snarkytart

Bump for FDA emergency use authorization for HCQ.


9 posted on 03/29/2020 9:24:45 PM PDT by TChad (The MSM, having nuked its own credibility, is now bombing the rubble.)
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To: snarkytart

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

CNN desperate for these drugs to fail so people will keep dying and the economy crashes ...


10 posted on 03/29/2020 9:28:07 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: DannyTN

“Why limited to only the drugs from the stockpile? Won’t that delay treatment while the drugs are sent out?”

No. there’s a nationwide shortage of these drugs right now, and these donations to the national strategic stockpile present a desperately needed massive new infusion of these drugs into the system ...


11 posted on 03/29/2020 9:30:13 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: snarkytart

Is there a reason the entire country is not on this if it proves effective?


12 posted on 03/29/2020 9:31:03 PM PDT by bray (Pray for President Trump)
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To: cba123; snarkytart

Worst flame war ever.

Nice to see.


13 posted on 03/29/2020 9:32:39 PM PDT by jdsteel (Americans are Dreamers too!!!)
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To: catnipman
“Why limited to only the drugs from the stockpile? Won’t that delay treatment while the drugs are sent out?”

To prevent people from hoarding like toilet paper.

14 posted on 03/29/2020 9:37:30 PM PDT by LisaFab
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To: DannyTN

It should be prescribed before hospitalization. I hope this will change. Maybe it’s because of the current supply. The supply is about to increase dramatically and when that happens, there’s no excuse for not prescribing it for everyone with symptoms. Then it could be prescribed for use prophylactically - like for malaria.


15 posted on 03/29/2020 9:37:51 PM PDT by Maurice Tift (Never wear anything that panics the cat. -- P.J. O'Rourke)
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To: snarkytart

How many thousands have to be cured before it’s no longer “anecdotal”???


16 posted on 03/29/2020 9:39:48 PM PDT by beethovenfan (Mene, Mene, Tekel, Upharsin)
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To: bray
Is there a reason the entire country is not on this if it proves effective?

They are not without their issues - heart arrhythmias, for one.

17 posted on 03/29/2020 9:40:13 PM PDT by Ranxerox
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To: Ranxerox

RA patients can get AFIB with it..I think they are still doing studies.


18 posted on 03/29/2020 9:45:34 PM PDT by RummyChick
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To: DannyTN; virgil
I think that those that test positive with health problems that put them in the high risk group should be prioritized to receive the therapy first.

A healthy 19 yr old who tests positive after returning from spring break should not receive it before your Grandmother in a nursing home.

Hydroxy is going to being limited supply until we ramp up production and get the pipline filled.

Here's the numbers from COVID Tracking Project (Have no idea if they're legit)

831,351 tested

692,290 neg 80% 139,061 pos 20%

19,730 hospitalized 14% of pos 2,428 deaths 1.7%

19 posted on 03/29/2020 9:46:23 PM PDT by Eagles6
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To: snarkytart

good news. looks like the lumbering behemoths of bureaucracy are slowly shaking themselves awake. as usual private labs and excellent doctors are/were working way ahead of them.


20 posted on 03/29/2020 9:48:00 PM PDT by dadfly
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