The Food and Drug Administration (FDA) is rescinding its recommendations on use of a drug once touted by President Donald Trump to be a “game-changer” in the fight against coronavirus.
Hydroxychloroquine was previously given “emergency use” authorization for patients hoping it could help in the treatment of the disease. That status was removed in an announcement from the agency on Monday.
FDA chief scientist Denise Hinton, writing to Gary Disbrow of the Biomedical Advanced Research and Development Authority, announced 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.”
“Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19,” Hinton added.
Trump had been touting hydroxychloroquine for months, recommending it without having scientific backing to support his claims on its efficacy.
“I’m seeing people dying without it…. When that’s happening, they should do it. What really do we have to lose?” Trump said in early April.
Evidence for hydroxychloroquine’s use being beneficial, however, was anecdotal, and not based on scientific studies. As more studies came out about the drug, for the most part, they seemed to suggest its use wasn’t a good idea.
One study focusing on VA patients who contracted COVID-19 found that those who were treated with hydroxychloroquine were actually more likely to die compared to those who were treated using conventional measures. Trump dismissed that article published toward the end of April, saying that he hadn’t read it yet. Days later, he continued to peddle the drug.
In the middle of May, Trump doubled down on hydroxychloroquine, telling reporters that he had begun using it weeks prior in a preventative way.
“I take it,” he said. “I hope to not be able to take it soon because, you know, I hope they come up with some answer. But I think people should be allowed to.”
After Trump’s announcement, Michael Ryan, director of the World Health Organization’s Health Emergencies Program, discouraged the use of the drug or its promotion outside of scientific trials looking into its potential for treating coronavirus.
“Every sovereign nation, particularly those with effective regulatory authorities, is in a position to advise its own citizens regarding the use of any drug…. I would point out, however, at this stage, [neither] hydroxychloroquine, nor chloroquine, have been, as yet, found to be as effective in the treatment of COVID-19 or in the prophylaxis against coming down with the disease,” Ryan said then.
According to reporting from Healthline, there are serious side effects in using hydroxychloroquine. For example, use of the the drug can lead to heart disease, including heart failure and arrhythmia, which can sometimes be fatal. Other side effects include vision impairment, which can sometimes become permanent.
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