The U.S. Food and Drug Administration warned patients against taking two malaria medications that have been talked up by President Donald Trump for COVID-19, unless carefully monitored in a hospital or as part of a clinical trial.
The FDA said it was issuing the warning for the drugs, hydroxychloroquine and chloroquine, after reports that patients taking them, especially in combination with the antibiotic azithromycin, had experienced heart issues.
“The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin,” the health agency said in the warning.
The agency has cleared some emergency uses of the medications, though it emphasized Friday that they haven’t been officially authorized for COVID-19 treatment or prevention. Doctors in the U.S. can prescribe whatever drugs they want, however.
Trump has latched on to the medicines, which are available as low-cost generics, as potential treatments for coronavirus patients. Limited evidence has suggested they might be helpful, but some wider trials have shown little or no effect. Research is continuing.
In its announcement, the FDA warned the drugs “can cause abnormal heart rhythms” as well as “a dangerously rapid heart rate called ventricular tachycardia.”
“These risks may increase when these medicines are combined with other medicines” including azithromycin, the FDA said. “Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.”
Representatives for the agency didn’t immediately respond to requests for further comment.
Trump has repeatedly backed the use of the malaria pill or the combination of drugs on Twitter and at briefings of the Coronavirus Task Force. In a press briefing on April 5, he said, “What do you have to lose? Take it.”
As researchers continue to examine whether the drugs might be useful, Trump’s remarks have attracted more controversy.
Prior to the FDA’s warning, an expert panel convened by the National Institutes of Health this week recommended against using the combination of hydroxychloroquine and the antibiotic azithromycin. And a senior health official responsible for coordinating research efforts for drugs and vaccines for the coronavirus said he was being pushed out of his role because of concerns he raised about the use of the malaria drugs.
The FDA also said Friday it was aware of a surge in hydroxychloroquine and chloroquine prescriptions being filled outside the hospital setting. The drugs have been added to the agency’s list of drugs in short supply, jeopardizing access for patients with lupus and rheumatoid arthritis, who take the drug for their conditions.
Medical experts have previously voiced concern about the potential heart risks associated with taking hydroxychloroquine with the antibiotic.
The American Heart Association, the American College of Cardiology and the Heart Rhythm Society issued guidance on April 8 stating that hydroxychloroquine and azithromycin “have potential serious implications for people with existing cardiovascular disease” and urged careful consideration of using them as COVID-19 treatments in combination, particularly given the two medications have not been studied together.
“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment,” said Robert Harrington, president of the American Heart Association, in a statement.
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