The US Food and Drug Administration on Friday warned against the use of two drugs that have been touted by President Trump as potential treatments for novel coronavirus.
The agency said the drugs, hydroxychloroquine and chloroquine, should only be used in hospital settings or clinical trials because of the potential for 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 medications that can affect the heart.
“We are also aware of increased use of these medicines through outpatient prescriptions,” the FDA said. “Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.”
Trump has mentioned the closely related drugs nearly 50 times since mid-March, according to a CNN analysis of his public comments.
The President has said the drugs would be a “game changer” in the fight against coronavirus, but a growing body of evidence suggests they may not help Covid-19 patients at all, and may do more harm than good.
“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19,” the FDA said on Friday.
The agency said it was monitoring serious side effects in coronavirus patients who took the drugs, either alone or combined with the antibiotic azithromycin or other drugs.
“These adverse events included abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death,” the agency said.
“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19,” he said, “there are known side effects of these medications that should be considered.”
In its statement, the FDA said those risks “may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial,” which is mentioned in an emergency use authorization for the drugs issued last month by the FDA.
“Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria,” the agency said, adding that hydroxychloroquine is also approved for certain autoimmune conditions such as lupus.
Patients taking the drugs for their approved indications should continue taking their medications as prescribed, the FDA said. “The benefits of these medicines outweigh the risks at the recommended doses for these conditions.”