The U.S. Food and Drug Administration on Friday cautioned against the use of malaria drug hydroxychloroquine, touted by President Donald Trump, in COVID-19 patients outside of hospitals and clinical trials, citing risks of serious heart rhythm problems.
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The decades-old drug has been called a "game changer" by Trump in the fight against the novel coronavirus and anecdotal reports that it may provide some benefit have spurred sales of the drug.
There is no evidence yet of the drugs' effect on the virus.
COVID-19, the disease caused by the new coronavirus, has no approved treatment or vaccine.
Within hours of Trump's initial endorsement on March 19, pharmaceutical supply chain experts reported shortages as doctors began prescribing hydroxychloroquine for themselves and their families. Patients have also pressured doctors to use the therapies widely touted by Trump and other supporters.
The FDA said on Friday it was aware of increased use of hydroxychloroquine and chloroquine through outpatient prescriptions and the drugs could cause abnormal heart rhythms and dangerously rapid heart rate.
The agency's announcement comes a day after the European Union's drug regulator warned of the side effects of the drugs, urging medical professionals to closely monitor patients on the medicines.
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Hydroxychloroquine was also associated with potentially higher risk of death for patients at U.S. veterans hospitals, according to an analysis submitted for expert review earlier this week.
Rick Bright, the ousted director of a U.S. agency charged with developing drugs to fight the pandemic, said on Wednesday he was dismissed because he called for careful vetting of the therapies.
The FDA has allowed healthcare providers to use the drugs for COVID-19 through its emergency use authorization, but has not approved them to treat the disease.
The heart rhythm risks may increase when the medicines are combined with other drugs, such as antibiotic azithromycin, as well as in patients with existing heart and kidney disease, the agency said on Friday. U.S. FDA warns against malaria drugs Trump championed for COVID-19.