FDA Revokes Emergency Use Approval For Hydroxychloroquine; Move slammed by Dr. Zelenko

Regulators from the Food and Drug Administration (FDA) today revoked emergency authorization given to the drugs chloroquine and hydroxychloroquine to treat coronavirus. The drug, touted by President Trump and Dr. Zev Zelenko, have been determined to not meet the “statutory criteria” to continue issuing an emergency use approval, according to the FDA.

Denise Hinton, the FDA’s chief scientist, wrote in a letter that “it is no longer reasonable to believe that oral formulations of HCQ (hydroxychloroquine) and CQ (chloroquine) may be effective in treating Covid-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

The FDA also said that, when taken together, hydroxychloroquine may interfere with the antiviral activity and effectiveness of remdesivir, another drug being used to treat Covid-19 patients.

Dr. Zelenko, who was a major force behind the widespread usage of hydroxychloroquine to treat coronavirus, responded to the FDA on Twitter, slamming them for using what he says is Nazi-like propaganda. “FDA announcement is misleading and uses Joseph Goebbels propaganda tactics. What the FDA needs to say is TREAT COVID-19 EARLY AND LIVE. Don’t end up in a hospital on a respirator and die.”

Asked about the FDA revoking the emergency approval, President Trump said that he “took it two weeks, and I’m here.” Trump said that he’s heard from many people who have been “so thrilled with the results of hydroxy.”

Proponents of using hydroxychloroquine continue to say that when administered in the early stages of a Covid-19 infection, the drug works wonders to keep the virus from ravaging the body. They also say that the FDA ignored this, and focused only on patients with more advanced cases of Covid-19, for whom the drug doesn’t appear to have the same positive effects as those in the early stages of infection.

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12 COMMENTS

  1. The point being that Dr. Zelenko is not an epidemiologist and is not an authoritative source for Coronavirus treatment. President is not affiliated in any way with the medical community and is certainly not an authoritative source for Coronavirus treatment.
    The FDA is an authoritative source and backs up their claims with pair reviewed studies.

    It’s not about US and THEM. It’s about our people and community, our doctors and the medical community that our doctors are part of. It’s about giving those of us in our hospitals the best chance of coming out of the hospital without bias or politics.

    • Unfortunately, it is THEM – the corrupt and greedy “deep state” elite that wants to control every aspect of our lives at our expense, for the greater good of the Earth vs. US the “undereducated” and “gullible” people.
      FYI Dr. Zelenko had only one Covid-19 fatality out of 1600+ confirmed covid-19 cases, 405 of them were high risk patients that got HCQ under his care. No practice in Lakewood, or better yet entire USA can claim similar success rate against Covid-19. His experience is real!
      So why is FDA trying so hard to protect US from using HCQ against Covid-19? The answer is as always Billions of our Tax-payer dollars that will go to Big Pharma’s bottomless pockets to create NEW and expensive Covid-19 drugs and vaccines. HCQ on the other hand is old, dirt cheep and very effective when used early on. So it does not fit THEIR objectives.
      THEY don’t care if thousands of people die!!! THEY think, less people = more resources. Less people = less carbon emissions. Especially when it’s the elderly who use the most and produce the least, that suffer the most from Covid-19.

    • Why is there not an intense activity to identify treatments that help patients avoid severe illness ? Apparently many of these treat early regiments show promising results. But the main authorities appear to give an impression of wanting to play down such “treat early solutions”.

  2. The FDA knows it is working, so that is why they want to stop its usage.

    How can they keep the fear going, and mandate the vaccine, if there is an easy and inexpensive cure for most people?

  3. How could we trust FDA? This was obviously a political move that will deprive thousands here in US and world wide of life saving medication. Who’s interests are they protecting?

  4. This is a meaningless directive. I would put this in the fake news category because it, in actual effect, doesn’t change anything.

    The move only means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.

    The original March 28th FDA EUA was for use in hospitalized COVID-19 patients. At that point, when a person needs to be hospitalized, they are most likely in the latter stages of the virus and have pre-morbidity conditions where HCQ is not very effective. However, at the onset and early stages of the virus.

    HCQ has an unmatched rate of cure, approaching 99% success, which is proven in numerous studies that the FDA has rejected out of hand while accepting the now infamous study published in Lancet which has now been retracted, as well as the de-bunked VA study.

    The main reason for the revocation of the FDA EUA is their claim that there might be serious cardiac adverse events associated with the drug whose risk outweighs the benefit.

    However, the antimalaria drug has received tremendous reviews from doctors all over the world and has been safely in use for decades against malaria, Lupus and, rheumatoid arthritis.

    The FDA’s concern was about extremely rare side effects such as heart arrhythmias and stroke which are only likely in patients with previous cardiovascular illness and embolisms, respectively.

    All told, this points to the close relationship between FDA and Big Pharma and the push for expensive, unproven alternatives such as Remdesvir and the ever-elusive vaccine.

    The take-away is that your doctor can still prescribe HCQ. It will be readily available, as always except that Federally associated facilities will not be getting their free stockpiles anymore, which affects nothing.

    This is just another false narrative promulgated by the corrupt FDA and media looking to continue their effort to control us all with more fear and panic.

    • Ron, you could not have said it any better – it almost seems like they don’t want it to work… they quote studies that were used in hospitals where the patients were already in bad shape. None of The studies include the zinc and azithromycin. Why don’t they conduct a study with patients showing early symptoms of covid and have them take the hydroclorxine zinc and azithromycin and let us see the results – Boeing was in the FAA’s pocket who’s in the FDA’s

  5. Need to abolish FDA and hippa. Forced scientists into too much paperwork. My son, a surgeon told me that without the FDA and hippa bottleneck, medicine would be ahead by 10 years!

  6. The FDA base their statements on a number of clinical studies that treated seriously ill patients with Hydroxycloroquine as the single treatment. Given the serious condition of the patients they were not in a phase where reducing virus replication has any effect. Unfortunately the FDA is taking these test results to represent ALL uses for Covid-19 and totally ignores the golden nugget; that treating EARLY saves lives !
    It is a tragedy that so little focus has been on really using what seems to work.

Comments are closed.