The FDA is issuing a new caution against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.
“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 and other QT prolonging medicines,” the FDA reported Friday.
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According to the FDA, hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19. They are being studied in clinical trials for COVID-19, and the FDA authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA).
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia, the FDA reported.
“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,” the FDA reported
Hydroxychloroquine and chloroquine are FDA-approved medicatinos used to treat or prevent malaria. Hydroxychloroquine also is used to treat some autoimmune conditions.
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