US FDA authorizes use of chloroquine and hydroxychloroquine to treat COVID-19 patients

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to the US Department of Health and Human Services’s (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) 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.

chloroquine coronavirus treatment“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” HHS Secretary Alex Azar said in a statement. “The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”

Hydroxychloroquine sulfate and chloroquine phosphate are oral prescription drugs approved to treat malaria and other diseases. Although there are no currently approved treatments for COVID-19, both drugs have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.

An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives.

Sandoz and Bayer are the latest companies stepping up to strengthen the U.S. response to COVID-19, and ASPR is working with additional companies willing to donate doses of hydroxychloroquine and chloroquine. Companies interested in donating goods or services should contact fema-nrcc-iagsupv@fema.dhs.gov or visit https://www.fema.gov/coronavirus/how-to-help.

Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis. Some states and retail pharmacies also have taken action to preserve the supply of these and other drugs for these patients.

In addition to accepting and distributing the donated medicines, HHS is funding clinical trials of two drugs, Kevzara (sarilumab) and remdesivir, and is supporting the earlier development of multiple potential therapeutic treatments, vaccines, and diagnostic tests for COVID-19.

Source: U.S. Department of Health and Human Services

MacDailyNews Take: This is excellent news that these promising drugs that may aid in the treatment of COVID-19 has been approved by the FDA!

29 Comments

    1. The side effects aren’t worth it you might live but you will be blind. There are many drugs that be use but they kill the patient. Both drugs are young people drugs they aren’t for the old. Toxic

      1. Quine is over 100 years old. The side effects are well known. The initial studies out of China and France indicate that low doses are effective for Covid 19. The serious side effects appear with larger doses.

      1. If it works, then it should be a tool in the right hands.
        It’s already approved for other uses and side effects for non-Covid cases are already known.

        1. Reads the actual study. It reports, no doubt accurately, that the 20 patients who received the drugs and completed the study (out of 26 originally) had a lower virus load than those in a 16-patient control group. That seems promising, although the sample size is hardly statistically significant. In the small print, it mentions that four patients who began the study did not complete it because they were transferred to an Intensive Care Unit and another because he died. Leaving those outcomes out of the results seems a bit troublesome.

  1. President Trump was lambasted by the usual suspects, yet, once again, it looks very much like he was right:

    I feel, as the expression goes, “What do we have to lose?” Because, you know, I feel very — I feel very good about it. Tony would feel, you know, like — he’d like samples done in a certain way. And I understand that too. Many doctors agree with that. We don’t have much time. You know, we have a lot of very sick people right now in hospitals all over the place… I feel very confident. I mean, I’ve seen things that surprise me, frankly. There are — as Tony said, there are other things we’re looking at too. Vaccine, of course, is incredible, but this is more immediate.

    Right now, this, to me, would be the greatest thing that could happen. This would be a gift from Heaven. This would be a gift from God if it works. So we’re going to pray to God that it does work. It’d be a fantastic thing.President Trump, March 21, 2020

    There’s been some tremendous signs that this could work. Now, again, you know, some doctors think it should go for years in testing. But, you know, this has been something that’s been around for many years. It’s been phenomenal — a strong, powerful drug for malaria. But we think it might work on this, based on evidence — based on very strong evidence. We’re going to see. President Trump, March 22, 2020

    1. He was lambasted for assuring the public that this was a miracle cure when there was little evidence of that. Same with assuring the public that the virus would miraculously disappear in April. Both things might be true, but they required evidence before being sold to the public as certainly true. Both assertions fell into a pattern of minimizing the threat, which has had the effect of lulling many of the President’s supporters into a sense of security that should have been exposed as false when he finally admitted yesterday that upto 2.2 million Americans might die without the sort of mitigation measures that he himself had been discouraging since at least February.

        1. What’s your point? If you’re trying to imply that anybody who objects to Donald Trump‘s behavior is a communist, then I have two Latin (not Russian) words for you: non sequitur.

      1. Hey, stop fellating yourself 🍆, stop fellating Creepy Joe Biden, and don’t fall over yourself as any kind of cunning linguist when it comes to Hilliery Clienton. Imagine if collapsing Clinton was the president now, she’d be peeing her panties.

  2. This is good news.

    But…
    The hazard here is people ingesting these chemicals on their own. Chloroquine and hydroxychloroquine are both toxic and should only be used at the direction and under the supervision of a doctor.

    1. True, but they are safe to use if taken as prescribed by a doctor who would have to actually prescribe it. Anyone taking something similar (fish tank cleaner) on their own should understand they are not taking it properly and are risking their lives.

      If taken as prescribed there is very little risk as the potential side effects have been well documented over the last 80 years. If there is a reasonable chance these known, safe drugs can help those recover from COVID-19, we owe it to them to try to help.

    2. Will it work for old people? +70 it’s very toxic, too much and you are blind and deaf, Hydroxychloroquine isn’t something to take first if at all, you want that ventilator.

    1. “SWPRS” is Swiss Propaganda Research, a group devoted to proving that the CIA and Council on Foreign Relations are the invisible hand behind everything from the Rwanda Genocide to Wikipedia to the war against the righteous government of Syria. Currently, they are devoting considerable resources to pushing the Edward Snowden narrative that Covid-19 is not a medical problem, but rather a psychological warfare operation for dubious purposes.

  3. As usual politics on this site has overtaken reasonable dialogue. I am a physician chloroquine and hydroxychloroquine are not safe to use by the lay public. Under a doctor’s supervision for normal use (auto-immune rheumatoid, lupus, etc) they are safe. Nobody, and I mean nobody knows if they are safe with COVID-19. What we do know is that people should not treat themselves with this to prevent the disease. It is an immunosuppressive, which means it will make a person more susceptible to catch the virus. Once a person is infected, it should not be used in early stages of the condition because it may encourage spread. The time to use it is by professionals, treating pneumonitis and pneumonia, as well as sepsis. All of which are problematic because of too strong an immune response. The FDA is allowing this because we are desperate for treatment and this is a reasonable thing to try in late stages of the illness by professionals who know the risks of this drug. It has a drug interaction profile that is huge and all this needs to be accounted for. The drug interactions cause problems with cardiac rhythm disturbances, which can be fatal. I know everyone on this site lately wants to praise or criticize Trump, but this is beyond the reasonable point. Let the pros figure this out!

    1. Dr. Zelenko has treated ~700 patients successfully, early on, to prevent them from proceeding to respiratory distress. Only 4 were admitted to the hospital, with no deaths.

      I think I’ll follow his advice…. HCQ + AZ + Zinc

  4. Plaquenil and Zithromax can be prescribed by your doc off-label. But there are potentially significant side effects. No free lunch. C-Pap machines are being used in the UK for less severe cases of respiratory distress, when there’s a shortage of ventilators.

    I highly recommend a 1hr video from an intensivist at Weill Cornell Medical Center in NYC. He’s at the front lines of the heart of the pandemic, 1200 beds all for Covid-19 patients. He answers alot of questions and gives advice on how to protect yourself and your family.

  5. Regardless of how effective these turn out to be, they join a convoy of potential therapeutics marching through clinical trials as we speak. Some of these stuffs will doubtless be effective at stopping the worst effects.

    If we can get a drug that reduces the rate of ICU cases to 10% of what they currently are (and likewise for deaths), countries that are running out of hospital beds might be able to regain control. It might even change the risk profile enough to allow more economic activity in countries currently under full lockdown.

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