MedWatch Update: Warning Issued on COVID-19 Drugs


The FDA has issued a warning against the use of hydroxychloroquine and chloroquine for COVID-19 outside a hospital or clinical trial setting due to the increased risk for heart rhythm issues. These medications have not been shown to be safe and effective for treating or preventing COVID-19. Earlier in the year, the FDA issued an Emergency Use Authorization (EUA) to allow the use of these medications to treat hospitalized patients, weighing 110 pounds or more, when a clinical trial is not possible and the provider feels potential benefits outweigh the risks under careful heart monitoring. Upon review of case reports and published literature of hydroxychloroquine and chloroquine, either alone or with azithromycin or other QT prolongation medications, the FDA was concerned about serious heart related side effects and deaths. QT-prolongation is a rare heart electrical condition that can cause dangerous heart complications. The FDA is recommending that patients who are prescribed these medications for FDA-approved uses, such as treating malaria or an autoimmune disease, continue to take the medication as prescribed and to speak with a health care professional if they have questions or concerns. The FDA is also cautioning patients to not buy supplies from illegal online pharmacies or consuming any form of chloroquine not prescribed by a healthcare professional. Prescribers are encouraged to monitor heart function, electrolytes, renal function, and liver tests along with any medications that could potentially cause QT-prolongation. Patients and health care professionals are encouraged to report any medication side effects to the FDA at this web link. You can read more about the FDA caution here.