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The US Food and Drug Administration on Friday warned against the widespread use of two antimalarial drugs — hydroxychloroquine and chloroquine — to prevent or treat COVID-19, noting they could cause serious side effects including heart problems and even death.
President Donald Trump has repeatedly touted the drugs as a possible treatment for the disease caused by the novel coronavirus. "What do you have to lose? Take it,” Trump said at coronavirus task force press briefing on April 5.
The FDA's warning comes as a growing number of studies and experts have raised concerns about the effectiveness of the drugs in safely and effectively treating COVID-19, for which there is currently no known cure.
A small clinical trial in Brazil was halted after some coronavirus patients being treated with chloroquine experienced irregular heart rates and more than a dozen died, according to a study published Friday. "The preliminary findings of this study suggest that the higher [chloroquine] dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir," the researchers wrote.
In March, the FDA approved the use of the drugs as a possible COVID-19 treatment in hospitals in certain situations. Several clinical trials are also underway to test the effectiveness of these drugs against the coronavirus. Outside of these settings, the FDA said on Friday, the use of the medicines is inappropriate and very risky.
"FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease," according to the drug warning. "These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening."
After reviewing cases in the FDA's own adverse events database, published medical studies, and reports in the American Association of Poison Control Centers National Poison Data System, federal officials concluded the drugs may cause "abnormal heart rhythms," "dangerously rapid heart rate," and pose risks when combined with other medicine used to treat COVID-19, such as the antibiotic azithromycin.
Talk of hydroxychloroquine and chloroquine as miracle drugs in response to the coronavirus pandemic has caused a run on pharmacies, triggering shortages for people who rely on the drugs to treat other serious medical conditions, such as lupus.
After pushing for more rigorous study of hydroxychloroquine as a coronavirus treatment, Rick Bright said he was recently removed from his role as director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, according to the New York Times.
"We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available," the FDA wrote.