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Hydroxychloroquine: no benefit for covid-19 patients 2:39
(CNN) - The United States Food and Drug Administration (FDA) warned on Friday about the use of two drugs that have been promoted by President Donald Trump as possible treatments for the new coronavirus.
The agency said the drugs, hydroxychloroquine and chloroquine, should only be used in hospital settings or clinical trials because of the possibility of serious side effects.
The agency said it was aware of reports of "serious heart rhythm problems" in covid-19 patients treated with the drugs, often in combination with azithromycin or other drugs that can affect the heart.
"We are also aware of the increased use of these medications through outpatient prescriptions," said the FDA. "Therefore, we would like to remind healthcare professionals and patients of the known risks associated with hydroxychloroquine and chloroquine."
- Study found no benefits of hydroxychloroquine, but an increased mortality rate in patients who took it for covid-19
Trump has mentioned drugs nearly 50 times since mid-March, according to a CNN analysis of his public comments.
The president has said that drugs would be a "game changer" in the fight against coronavirus, but mounting evidence suggests that these drugs may not help covid-19 patients at all, and may instead do more harm. how good.
"Hydroxychloroquine and chloroquine have not been shown to be safe and effective in treating or preventing covid-19," the FDA said Friday.
The agency said it was monitoring serious side effects in coronavirus patients who took the medications, either alone or in combination with the antibiotic azithromycin or other medications.
"These adverse events included abnormal heart rhythms, such as QT prolongation, a dangerously fast heart rate called ventricular tachycardia, and ventricular fibrillation and, in some cases, death," the FDA said.
- Chloroquine and hydroxychloroquine: Cardiac risk concerns increase over use for covid-19 treatment
"We understand that healthcare professionals seek all possible treatment options for their patients and we want to make sure we provide them with the appropriate information necessary for them to make the best medical decisions," said FDA Commissioner Dr. Stephen Hahn in a release.
"While clinical trials are ongoing to determine the safety and effectiveness of these drugs in fighting covid-19," he said, "there are known side effects of these drugs that should be considered."
In its statement, the FDA said those risks "can be mitigated when healthcare professionals closely evaluate and monitor these patients, such as in a hospital setting or in a clinical trial," which is mentioned in an emergency use authorization. for medications issued last month by the FDA.
"Hydroxychloroquine and chloroquine are approved by the FDA to treat or prevent malaria," the agency said, adding that hydroxychloroquine is also approved for certain autoimmune conditions like lupus.
Patients taking the medications for their approved indications should continue to take their medications as prescribed, the FDA said. "The benefits of these medications outweigh the risks at the recommended doses for these conditions."
covid-19
