The US FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA.
These risks, which are in the drug labels for their approved uses, may be mitigated when healthcare professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat 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. We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind healthcare professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information.Source: FDA
“We understand that healthcare 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,” said FDA Commissioner Stephen M. Hahn, MD. “While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage healthcare professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”