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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: jonrick46

I am pointing out that even if 300 million pills are donated, that’s not a treatment for 300 million Americans. The donations are good, but we’re going to need a lot more than what’s been donated and it will take some time to spin up production.

As for the vaccine, we’re at least 6-18 months out from the first generally available one at a minimum. We’ll have to treat people in the interim.


61 posted on 03/30/2020 12:33:53 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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To: Trump Girl Kit Cat

There have been early reports of relapses. There is a lot that is *not* known about this virus. But the point I was making is that one pill does not equal one full course of treatment, unlike what some people on FR seem to think.


62 posted on 03/30/2020 12:35:36 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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To: Trump Girl Kit Cat

The Bayer operations are good, but we do still have an actual shortage of HCQ at current and will for at least the next several weeks.

Azithromycin is manufactured all over the globe. It’s the second most prescribed drug in the US at current, so there are lots in stock. Here’s a list of all the people that make it: http://www.antimicrobe.org/drugpopup/Azithromycin%20-%20Brand%20names.htm


63 posted on 03/30/2020 12:39:06 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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To: Trump Girl Kit Cat

120K out of 990K is not 1/10% - it’s more than 10%.


64 posted on 03/30/2020 12:39:59 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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bkmk


65 posted on 03/30/2020 12:49:29 AM PDT by mad_as_he$$
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To: Ranxerox

No prescription drug is without side effects or issues. For that matter, no OTC drug is either.

When you need either bad enough, you take it and risk the side effects.


66 posted on 03/30/2020 1:02:05 AM PDT by LateBoomer
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To: Spktyr

Why would we need to treat 300 million Americans? Right now we have 142,735 cases. Besides lots of hydroxychloroquine and chloroquine are coming:

https://www.politico.com/amp/news/2020/03/29/fda-emergency-authorization-anti-malaria-drug-155095


67 posted on 03/30/2020 1:18:53 AM PDT by jonrick46 (Cultural Marxism is the cult of the Left waiting for the Mothership.)
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To: snarkytart
1) Know that the FDA is covering their butts legally as much as they can with this statement as there are a horde of lawyers ready to sue whomever they can. Doctors and nurses and administrators are often in the lawyers interest.

2) Know that the chances are, that with this proving effective, the supplies will quickly run out. Thus the "stockpile" and with it controls so that it goes to patients who are sick and not to all the celebrities who are afraid they might catch it. This is a war with a virus not a feelings contest.

3) Notice that it was done on an "emergency" basis and calls for studies while it is used. Again, this is to cover there butts some more as in #1. But moreover (pardons the butt pun) this is so that some statistics can be gathered along the way with this process so they can figure out what works and what doesn't on an "Emergency" basis.

Medicine is all about what works and getting effective treatments to as many as truly need it during difficult times. That truly is going to mean "Prioritization" which the press and public is not probably going to like. Drugs must be funneled to those to patients with tested symptoms that it will help the most and to the Doctors and Nurses (if it can be used effectively) so they will not be knocked out and hopefully not becoming vectors themselves.

The War with COVID-19 is on and the FDA knows it. And they know that this is on top of the Yearly Flu War which is a mutating B*STD.

Hopefully COVID-19 will begin to Peak and taper off and the FDA and the medical community can learn something from it.

Without the FDA, I am confident the drug would quickly disappear into the hands of those who wish to profit from it and those who do not need it. My prayers go with the FDA and all those in the Medical community that are fighting this new war - THEY NEED IT!

68 posted on 03/30/2020 1:22:42 AM PDT by CptnObvious (Question her now.)
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To: MHGinTN

+1 = Zinc...my fine sir?

And thank you for the mail! I have been planning to get back to you because I too am intrigued by certain rumored revolutionary developments in regards to new sources of energy ... but have been on an all-consuming crusade to educate the public on the subject of this thread.

Hope you are well and again, thank you for taking the time to in-box me. Hope to find out if you have an opinion on the potential of quantum ferrofluids and superfluidity as it relates to the subject of this video and/or the topic you referenced in the message you sent me.

https://youtu.be/BSR6EDMv7PI


69 posted on 03/30/2020 1:37:04 AM PDT by PresidentFelon
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To: jonrick46

See my post number 62. One pill does not equal one completely treated American, unlike what several here on FG seem to think. We’re going to need more than just 143K sets worth for treatment between now and when we get a working vaccine.


70 posted on 03/30/2020 1:44:26 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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To: Spktyr

I am not a doctor and have no idea how many doses are needed for a full treatment. I am sure the experts have determined what the projected cases numbers will need treatment. By multiplying that number by the doses needed for treatment will be a way to guess the number of doses needed. Another thought is we will not need all of that medicine at one time. There is a range of time that the infected will be treated. All we need is stay ahead of the curve.


71 posted on 03/30/2020 2:06:42 AM PDT by jonrick46 (Cultural Marxism is the cult of the Left waiting for the Mothership.)
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To: jonrick46

FYI, it is currently either 12 or 14 pills for a full regimen (cannot recall which due to the hour). Plus what may be needed for prophylactic use by medical workers, as early reports indicate it may have that property too.


72 posted on 03/30/2020 2:13:46 AM PDT by Spktyr (Overwhelmingly superior firepower and the willingness to use it is the only proven peace solution.)
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To: dadfly

“Aiyee Tila, she is a big one.”

- (Gunga Rom, the elephant boy)


73 posted on 03/30/2020 3:03:41 AM PDT by FroggyTheGremlim (I'll be good, I will. I will.)
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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.”

Where in the flying F are they coming up with this? There have been dozens of news accounts of hydroxychloroquine’s effectiveness. What planet are these idiots living on??


74 posted on 03/30/2020 3:38:38 AM PDT by ScottinVA (Prayers up for Rush Limbaugh...)
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To: Trump Girl Kit Cat

60%


75 posted on 03/30/2020 3:42:07 AM PDT by Cobra64 (Common sense isnÂ’t common anymore.)
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To: dadfly
I know my fellow incompetent DC residents. They don't move quickly, they don't move willingly, they don't see any reason why they should move and for the most part they don't move. In fact, as far as they are concerned, they are in charge and no one has the authority to tell them to move any faster than they - the anointed ones - decide for themselves that they should move, which, again they are not about to do.

The orange mahout must have wielded a YUUUUGE stick.

76 posted on 03/30/2020 4:05:05 AM PDT by AndyJackson
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To: virgil

Perhaps - once there is sufficient dosages available - else you would be dosing a lot who would never come close to dying while others didn’t have a chance w/o something helpful..


77 posted on 03/30/2020 4:09:54 AM PDT by trebb (Don't howl about illegal leeches, or Trump in general, while not donating to FR - it's hypocritical.)
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To: Trump Girl Kit Cat

Check your math.
120,000 cases/990,000 = 0.12 which is 12%.
So 12% of the cases we have tested have come back positive.

990,000 is great though!!!

The good news, is that we are now testing most of the people who have symptoms, and probably of the medical professionals who have had exposure and a good number of other people who were exposed.

That’s one of the keys to getting this contained.’


78 posted on 03/30/2020 4:32:25 AM PDT by DannyTN
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To: jonrick46

“Why do you say “there’s a nationwide shortage of these drugs”?said Thursday it will donate 6 million doses of hydroxychloroquine to the United States?”

because:

A. the normal amount of hydroxychloroquine in the pipeline is just enough for those few who take it for lupus and rheumatoid arthritis, and it’s not even the best medicine for RA anyway as the biologics work WAY better, so those who can, take the biologics ... however, the sudden demand by doctors, hospitals and such for hydroxychloroquine prophylaxis and treatment has sucked that limited supply right out of the pipeline, leaving lupus and RA patients temporarily high and dry ...

B. The donations you reference have been made to the national strategic stockpile and NOT to the normal supply line AND they were just made in the last couple of days; nonetheless, utilizing the new stocks of hydroxychloroquine in the national strategic stockpile for C-19 purposes should reduce the pressure on the normal supply, so folks who have been taking it along along for lupus and RA should hopefully be able to acquire their needed medications ...


79 posted on 03/30/2020 4:49:31 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: PresidentFelon

You have absolutely no idea how a patient with a red blood cell disorder that also has two separate disorders that cause the heart to stop beating will react as this virus attacks the heart..do you?

So you cant say it is safe for everyone

I prefer to do what i have been doing for weeks...find something that does the same thing as this medicine that doesnt requie a script with the virus already taking hold


80 posted on 03/30/2020 4:57:14 AM PDT by RummyChick
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