The FDA just revoked an emergency OK for the malaria pill hydroxychloroquine in coronavirus patients, as clinical evidence piles up against the drug
healthregulators will no longer allow the emergency use of chloroquineor hydroxychloroquineto treat COVID-19.
- The Food and Drug Administration said Monday it has revoked the emergency use authorization issued for the antimalarial medications.
- The FDA had previously allowed the drugs to be used in hospitalized COVID-19 patients. Clinical trials testing hydroxychloroquine will not be affected by the change.
- FDA reviewers concluded that chloroquine and hydroxychloroquine "are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA."
- The decision also acknowledged "serious" heart-related side effects that the pills can cause.
US health regulators reversed Monday a decision to allow the use of hydroxychloroquine and chloroquine to treat COVID-19.
The Food and Drug Administration issued an emergency use authorization in late-March for the malaria pills. It specified they could be used in hospitalized COVID-19 patients who could not enroll in a clinical trial. Hydroxychloroquine was first approved in the 1950s and is used by many people to treat lupus or arthritis.
An emergency use OK is not full FDA approval. The bar of evidence is lower for emergency use, allowing regulators to consider both the potential and known benefits and risks for a drug. Standard approval requires the demonstrated benefits outweigh the known risks.
The FDA said the drugs "are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA."
The agency noted that because of heart issues and other side effects in patients taking the medications, the existing and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the risks associated with its use.
Read more: Drugmakers are racing to find ways to treat the novel coronavirus by repurposing existing medications. Here's what you need to know about remdesivir and 15 other leading treatments.
The effectiveness of hydroxychloroquine has been mired by a torrent of low-quality clinical trials over the past months.
In the last couple weeks, however, a few high-quality studies produced results that clarified the picture and suggest the pills are not particularly effective — if at all — in fighting the
Earlier this month, one randomized trial found it did not help prevent COVID-19 infections in people who were likely exposed to the virus. And a large British study of hospitalized patients found no clinical benefit for hydroxychloroquine, researchers said on June 5.
While well-designed studies found no benefit for taking hydroxychloroquine against this outbreak, some research has raised concerns about the potential for the medication to cause heart problems.
Read more: Several new studies are raising fresh doubts on whether malaria pills should be used to treat the coronavirus, and a top US health agency just warned against widespread use
Throughout March and April, President Donald Trump consistently touted the prospects of hydroxychloroquine by name. In a March 21 tweet, Trump said that a combination of the drug with an antibiotic called azithromycin has "a real chance to be one of the biggest game changers in the history of medicine."
Read more: 10 drugmakers are working together to develop a treatment based on the blood of COVID-19 survivors, and they plan to start testing in humans next month
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