FDA gives emergency approval to Hydroxychloroquine & Chloroquine to treat COVID-19

NightHawkeye · Mar 30, 2020

From the "We're officially ignoring the French studies but providing approval anyway", files: FDA gives anti-malaria drugs emergency approval to treat COVID-19 | ABC News

In a statement released Sunday night, the U.S. Department of Health and Human Services announced it had received 30 million doses of hydroxychloroquine sulfate and one million doses of [c]hloroquine phosphate donated to a national stockpile of potentially life-saving pharmaceuticals and medical supplies. Hydroxychloroquine and chloroquine, which are oral prescription drugs used primarily to prevent and treat malaria, are both being investigated as potential therapeutics for COVID-19.

The statement noted that the FDA had issued an emergency-use authorization to allow both donated drugs "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."

Jonathan Walkerin · Mar 30, 2020

That should at least give plenty of test subjects that accurate numbers can be established.

Johan_1988 · Mar 30, 2020

It's use has seen great success so far and has shortened recovery times from weeks to day's. It has also helped elderly patients recover. So a very good move by the US FDA. Just hope the rest of the world follows suit. In my country it can really help with all the people who have HIV and TB whom are most vulnerable and with our elderly folks as well.

Here Kitty Kitty · Mar 30, 2020

I hope it works! It's scary not to have medical testing done beforehand, but we can't really wait when it's coming down to death without treatment.

rjs330 · Mar 30, 2020

I'm glad we are giving it a shot. We don't know it will work for everyone, but at least we are trying. Even if it doesn't help in all cases, if it helps the majority then it's worth it. If it stops or slows the death rate that's excellent.

essentialsaltes · Mar 30, 2020

NightHawkeye said:
The statement noted that the FDA had issued an emergency-use authorization

EUA's are only supposed to be issued when the benefits outweigh the risks. It will be interesting to see if this has been evaluated by FDA.

(see also)

rambot · Mar 30, 2020

Yup. Try anything. I'm sure good and rigourous scientific study will come out of this too. Best of luck for those involved!

NightHawkeye · Mar 31, 2020

Here Kitty Kitty said:
I hope it works! It's scary not to have medical testing done beforehand, but we can't really wait when it's coming down to death without treatment.

Exactly!

As with many adversities in life one must face them prepared only with what's at hand, not with what one might like to have.

sfs · Mar 31, 2020

essentialsaltes said:
EUA's are only supposed to be issued when the benefits outweigh the risks. It will be interesting to see if this has been evaluated by FDA.

The public health people I know are baffled by this action, since it's based on essentially no evidence. Their conclusion is that it must be a political decision.

SoldierOfTheKing · Apr 2, 2020

sfs said:
The public health people I know are baffled by this action, since it's based on essentially no evidence. Their conclusion is that it must be a political decision.

There can’t be evidence one way or the other until it’s tried. That’s how science works.

jacks · Apr 2, 2020

If I had corona-virus I would certainly like the option to try this drug. HERE is the FDA Fact Sheet on it.

Michael · Apr 2, 2020

Trial drug can significantly block early stages of COVID-19 in engineered human tissues

They have started to test a promising new drug (hrsACE2) on engineered human cells that seems to inhibit the coronavirus too. Things are looking up.

In cell cultures analyzed in the current study, hrsACE2 inhibited the coronavirus load by a factor of 1,000-5,000. In engineered replicas of human blood vessel and kidneys -- organoids grown from human stem cells -- the researchers demonstrated that the virus can directly infect and duplicate itself in these tissues. This provides important information on the development of the disease and the fact that severe cases of COVID-19 present with multi-organ failure and evidence of cardiovascular damage. Clinical grade hrsACE2 also reduced the SARS-CoV-2 infection in these engineered human tissues.

Michael · Apr 2, 2020

jacks said:
If I had corona-virus I would certainly like the option to try this drug. HERE is the FDA Fact Sheet on it.

I would too. Considering the amount of lung damage alone that the corona virus can cause, I'd be inclined to take my chances with a possible cure rather than just let it run it's course, particularly if things started to go downhill and hospitalization was required.

I think this is a reasonable option at this point in time actually. A full and complete scientific "test' is in order of course, but I think you could find any number of willing test subjects about now.

essentialsaltes · Apr 2, 2020

SoldierOfTheKing said:
There can’t be evidence one way or the other until it’s tried. That’s how science works.

In a controlled experiment where people are taking data down, yes, but that's not what's happening.

FDA just gave approval for it to go out into the public. No one is collecting information on efficacy. Even if someone was collecting information, nothing is blinded, much less double blinded. There still won't be any evidence.

Michael · Apr 2, 2020

essentialsaltes said:
In a controlled experiment where people are taking data down, yes, but that's not what's happening.

FDA just gave approval for it to go out into the public. No one is collecting information on efficacy. Even if someone was collecting information, nothing is blinded, much less double blinded. There still won't be any evidence.

It might be possible to look at the death rates of early cases here in the US, and compare them to the ages and death rates of patients who test positive and who are then given these drugs. It's not a perfect test of course, but considering the circumstances, I think it's a reasonable compromise.

I certainly wouldn't want to be part of a test program and provided only a placebo.

sfs · Apr 2, 2020

SoldierOfTheKing said:
There can’t be evidence one way or the other until it’s tried. That’s how science works.

And there are lots of people trying in systematic ways already. I'm not just being pedantic here -- I've seen any number of highly touted drugs that lots of people were sure were going to be great, for everything from cancer to acid reflux to Ebola. Most of them turn out to be not so good in the end.

essentialsaltes · Jun 15, 2020

FDA revokes emergency authorization for antimalarial drugs touted by Trump as covid-19 treatment
The agency said hydroxycholoroquine and a related drug probably don’t work.

The FDA said it had concluded that it “is no longer reasonable to believe” that hydroxychloroquine and chloroquine are effective in treating the disease. “Nor is it reasonable to believe,” the agency said, "that the known and potential benefits of these products outweigh their known and potential risks.”

Larniavc · Jun 15, 2020

essentialsaltes said:
FDA revokes emergency authorization for antimalarial drugs touted by Trump as covid-19 treatment
The agency said hydroxycholoroquine and a related drug probably don’t work.

The FDA said it had concluded that it “is no longer reasonable to believe” that hydroxychloroquine and chloroquine are effective in treating the disease. “Nor is it reasonable to believe,” the agency said, "that the known and potential benefits of these products outweigh their known and potential risks.”

Who knew that Mr Trump would be very definitely wrong about this?

sfs · Jun 15, 2020

The FDA also issued a warning today that administering both hydroxychloroquine and remdesivir together could reduce the effectiveness of the latter.

FDA gives emergency approval to Hydroxychloroquine & Chloroquine to treat COVID-19

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