FDA issues warnings about hydroxychloroquine and chloroquine

FDA issued a Drug Safety Communication on Friday, warning about the known adverse effects associated with hydroxychloroquine and chloroquine, including serious and poten

FDA issued a Drug Safety Communication on Friday, warning about the known adverse effects associated with hydroxychloroquine and chloroquine, including serious and potentially fatal heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, which are not approved by the agency. According to FDA, the risks—which are listed on the label for the drugs' approved uses—may be mitigated when health care professionals closely monitor and supervise these patients, such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization for these drugs to treat COVID-19. "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," 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." The Drug Safety Communication notes that FDA has reviewed, and is continuing to investigate, case reports in the FDA Adverse Event Reporting System database regarding serious heart-related adverse events and death in patients with COVID-19 who are taking hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other drugs. These adverse events included abnormal heart rhythms such as QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some instances, death. FDA said that individuals with other health issues, such as heart or kidney disease, are potentially at greater risk of these heart issues when taking these drugs.