The Food and Drug Administration on Friday cautioned against the use of hydroxychloroquine, a malaria drug originally approved in 1955, to treat Covid-19 outside of the hospital or in the setting of a clinical trial. The drug has been repeatedly touted by President Trump as a potential treatment.

In a drug safety communication meant for health care providers, the FDA said it is “aware of reports of serious heart rhythm problems” in patients with Covid-19 treated with hydroxychloroquine or an older drug, chloroquine. The agency said it seeks to “remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.”

“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” FDA Commissioner Stephen Hahn said in a statement. He said that the FDA encourages health care professionals to “closely screen and monitor” those patients who doctors decide to give the drugs to mitigate potential risks.

advertisement

Hydroxychloroquine is a widely available generic drug, and manufacturers including Novartis and Teva have donated millions of doses. It was one of the first medicines identified in lab tests to have potential to fight the coronavirus SARS-CoV-2, which causes Covid-19.

Early reports, including several from a controversial French researcher, Didier Raoult, led to early enthusiasm for the drug. President Trump repeatedly expressed enthusiasm for it during White House press briefings, and the drug was commonly mentioned by television commentators on Fox News. 

advertisement

But medicines that show promise in early studies frequently show no benefits in clinical trials, and data on the medicine have been more mixed, with some small studies showing a benefit, others showing none, and a few indicating that patients might be harmed by the drug.

In a paper published in Nature Medicine Friday, researchers at New York University wrote that of 84 consecutive patients treated with the combination of hydroxychloroquine and azithromycin, an antibiotic, 9 had changes in the QT interval, a measure of electrical pulses in the heart, that would put them at heightened risk of a severe arrhythmia or sudden cardiac death.

“Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia,” the FDA said in its warning. “These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.”

The agency clearly states in the document that use should be restricted. “To decrease the risk of these heart problems that can be life-threatening, we are warning the public that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, when used for COVID-19 should be limited to clinical trial settings or for treating certain hospitalized patients under the EUA,” the agency said. “FDA will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19, and we will communicate publicly when we have more information.”

The EUA, or emergency use authorization, was an earlier clearance granted on March 30 to allow the use of hydroxychloroquine from a government stockpile to treat patients in the hospital. In an April 14 article in the New England Journal of Medicine, two doctors at Harvard’s Brigham and Women’s hospital, Benjamin N. Rome, and Jerry Avorn, wrote that the EUA was “widely yet incorrectly reported by Trump and others as meaning that the FDA had approved the drugs for this indication.” In the article, Rome and Avorn warned: “These developments represent fundamental threats to the U.S. drug-evaluation process.”

Lacking other options, doctors appear to have used hydroxychloroquine widely in hospitalized patients, and its use was recommended in guidelines produced by major hospitals. However, the drug’s exact benefit has been unclear, with some physicians reporting dramatic results and others not seeing much benefit at all.

One problem is that exactly how sick patients become with the disease is unpredictable, meaning that results can depend as much on which patients are selected for a study as which treatments are used. The only way to be sure is to randomly assign patients to a placebo.

More than 133 studies are currently running to determine if hydroxychloroquine is effective in various stages of Covid-19. Some results are expected soon, including results from a University of Minnesota study that aims to see if the drug can prevent infection in health care workers. Recently, Novartis announced it would fund its own study of the drug. It is also being studied in large studies run by the U.K. government and the World Health Organization.

“The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available,” Hahn said in his statement.

  • The agency also said it became aware of reports of “serious heart rhythm problems” in patients with the virus who were treated with the malaria drugs. The CDC recommends wearing a cloth face mask in public to help slow the spread of coronavirus. The problem is where do I get it? Everywhere is out of stock.

    • Mine was delivered yesterday. It is a great deal, and I don’t have to go out and get infected while I am looking where to buy. Thank you.
      The grocery chain makes coronavirus face coverings mandatory for customers, so you can’t get in without it. All must wear a mask. It might stay like this until next year.

  • One thing FDA could do to save lives would be to approve the use of modern day “iron lung” negative pressure exoventilators with Cuirass in lieu of lung damaging intubated positive pressure ventilators for critical Covid19 patients. This has potential to save 50% of the lives being lost.

  • When STAT first talked about HCQ + Zpak being used for Covid19 treatment, I commented that it was “worthless”. The majority of the respondents wrote to me that I was uneducated and did not know what I was talking about……..

    • The game is an over on hydroxychloroquine. Thousands of patients are being treated by this drug as prescribed by their doctors. Let’s wait till all the evidence is in.

  • The President should stick to politics, not encourage folks to public anti-pandemic views. Not e courage people to use any medicine not tested for a cure. Not take bleach or disinfection into our bodies. He also has withheld pain medications to the chronically I’ll through his “pals” who are CEO’s of corporate businesses. It took so many deaths from this Covid 19 virus to show the American people how truley inept he is at being a doctor.

    • On the remote possibility that this comment was in response to my earlier one, please understand that I believe President Trump and all other politicians should refrain from practicing medicine and focus on prudent steps to assist all of us who are fighting this disease and it’s unwanted and devastating repercussions. Likewise I was making the point that media folks should shoot straight when they report on healthcare (and other) events and issues, and when they want to share their biases with readers (some might say force feed them to us) they should clearly label those views as opinions instead of as news.

      I’m not defending politicians on either side of the aisle – there’s plenty of fault to be found with both. In fact, the point of my comment was to encourage Stat’s Editors and Writers to stick to reporting on healthcare and leave politics to others. And yes, I know in today’s world that’s probably not likely to happen.

      Just wanted to be sure that my earlier comment wasn’t misinterpreted. I don’t think it serves any useful purpose to criticize (trash might be a better word) politicans of either party when commenting on these articles, but I’m not naive enough to believe that those who are inclined to feel and do otherwise will be moved to change their behavior.

    • Never heard of such a rule for politicians. Should they also not comment on global warming? Well Trump has not encouraged anyone to use this drug without their doctors approval. All he said was let’s give it a chance. Donald Trump is the most unfairly treated person in history.
      No his exact words regarding the disinfectant.

      “I see the disinfectant that knocks it out in a minute, one minute. And is there a way we can do something like that? By injection inside or almost a cleaning, cause you see it gets in the lungs and it does a tremendous number [on the] lungs: so it would be interesting to check that. We’re going to have to use medical doctors, but it seems interesting to me”

      Nothing in that quote says anything about injecting actual disinfectant. Did you think that Edward Jenner recommended injecting actual virus in order to kill people? Because it’s the same exact point.
      Another lie propagated by the media.

      Do you have any evidence regarding the pain medication accusation? I’d like to debunk that one as well. Donald Trump is saving lives with his actions. Andrew Cuomo recommended COVID-19 patients be allowed back into nursing homes in order to killDo you have any evidence regarding the pain medication accusation? I’d like to debunk that one as well. Donald Trump is saving lives with his actions. Andrew Cuomo recommended COVID-19 patients be allowed back into nursing homes. Shouldn’t the media be discussing this?

  • Tip of the hat to Robert Emmett. You nailed it with your thoughtful and well-reasoned discussion of this issue, IMO.

    Like a previous commenter I feel that Stat News writers should err on the side of caution and either play it straight by providing balanced and fair analysis and commentary OR post their articles as Opinion pieces rather than “News”.

    I’m a recent subscriber to this publication. If you play it straight and leave out the political slant and jabs at the President I’ll continue to read your articles and support your work. If not I’ll look elsewhere for true news reporting instead of opinionated commentary masquerading as news.

    We’re all in this together, and your written reporting on healthcare related news and topics should, IMO, be as non-partisan as possible. Clearly and completely non-partisan.

    If your Editors and Writers adhere to this high standard you’ll produce a publication you can be proud of and that I and the rest of your readers will welcome.

  • This brief article and the FDA warning it describes appears disproportionately concerned with QT intervals in this study which produced no deaths, while the deadly effects of the COVID-19 pandemic on these patients were not even addressed. No attempt is made, either in this miniscule study or by the FDA, to suggest the relative value of treating COVID-19 patients with this regimen. Instead, all attention was drawn to cardiac RISKS rather than cardiac DAMAGE done to the patients studied here. One would think from this one-sided coverage that the primary danger we face is now cardiac in nature, and that HCQ/azithromycin should be removed and saved for a small niche of patients – when the results of this trial show just the opposite: i.e., monitor cardiac-impaired patients, but prioritize COVID-19. The fact that this trial included NO discussion about the long safety record of these medications in the one-page study, with its paltry 84 patients and 10 references, gives a one-sided, skewed view unsubstantiated by actual safety/efficacy results of the countless patients receiving this regimen. The researchers ignored the overarching issue, which is the risk/benefit ratio of administering vs. failing to administer hydroxychloroquine/azithromycin to COVID-19 patients, and focusing instead on the elevated QT interval of cardiac patients.

    • And haven’t we read that COVID-19 itself may be causing heart damage following recovery as well as lung and kidney damage. So why criticize possibilities alone with a drug that has been somewhat successful in early stage of COVID-19. Provide the cautions along with the benefits.

  • It might do better justice to change the headline and be more honest than political, but since YOU want to go there: Mr. Trump’s going to win big in 2020. People will crawl through a skanky swamp like this one, to get to the polls. Thank God for His good earth and the things He provides for us so others cannot take advantage. Hopefully universities will go back to their old ways when they produced real conservative doctors who truly cared, who had a calling to help and bless others. Make America Great Again, God, use our Mr. Trump get us back to a time when doctors really cared and we weren’t just sheep only led to shearing or slaughter.

    • Belongs in the opinion section. Was impressed with other authors / Statnews until “news” like this.

      Editor: move the article to opinion section or lose your objective and unbiased status.

      PS not a fan of either party and their stances and want honest news. Period.

  • Well why are there Doctors using these drugs then and having and patients getting better. Its the FDA AND OTHER QUAKES DON’T WANT PEOPLE USING THIS MEDICINE. A BIG CONSPIRACY IS GOING ON. IF YOU DON’T BELIEVE ME JUST WAIT.. You will be in line getting a Shot of no telling what and a CHIP IN YOUR HAND ALL BY BILL GATES AND DR TONY FUCIE.
    SO THEN THEY CAN TRACK YOU.
    RIGHT NOW THIS 6 FOOT THING IS A EXPERIMENT FOR A SATILITE VIEW.

    • You’re right. This is an experiment on how much liberty you can take from the people before they will kick. Notice that Trump realizes this, hence his stand on having governors making closure decisions regarding their states rather than a federal mandate that would impose dictatorial controls over the entire country. Notice also who keep calling for federal mandates…… the socialist left. Thank God we have President Trump.

    • You got beef with Democratic socialism there Rex? You DO know the US military is a (gasp) SOCIALIST organization right? As a veteran myself, I enjoyed affordable housing and food, tuition assistance, and universal health care while I was in. Those are the main pillars of a social welfare system my dude.

Comments are closed.

Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy