FDA Issues Safety Warning on Two Potential COVID-19 TreatmentsBy
The US Food and Drug Administration (FDA) has issued a drug-safety communication for hydroxychloroquine and chloroquine, two drugs being evaluated as potential treatments against the novel coronavirus (COVID-19).
“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,” said the FDA in its April 24, 2020 communication. “We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. FDA will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information.”
To decrease the risk of these heart problems, the FDA is advising that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, when used for COVID-19 should be limited to clinical-trial settings or for treating certain hospitalized patients under an emergency use authorization (EUA).
In its safety communication, the FDA says that 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 through an EUA. The medicines being used under the hydroxychloroquine/chloroquine EUA are supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.
“It is reported that hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia, and that these risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic, azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition,” said the FDA in its communication. “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.”
Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
Source: US Food and Drug Administration