While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use

FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine & chloroquine, including potentially life-threatening heart rhythm problems, reported with their use for treatment or prevention of #COVID19, for which they are not FDA-approved.

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 to make the best medical decisions.

Hydroxychloroquine & chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus & rheumatoid arthritis. These medicines have not been proven safe or effective for treating #COVID19, but clinical trials are underway.

We encourage health care professionals making individual patient decisions closely screen & monitor patients to help mitigate these risks. FDA will continue to monitor & investigate potential risks & will communicate publicly when more information is available.

Once FDA has approved a drug, health care providers generally may prescribe or administer the drug for an unapproved use based on their assessment of potential benefits versus risks for their patient, recognizing FDA has not assessed the safety or effectiveness of such use.

For this reason, it is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with hydroxychloroquine and chloroquine, and are included in the drug labels for their approved uses.