FDA: Improper use of hydroxychloroquine, chloroquine for COVID-19 may increase risk for arrhythmias, death
The FDA issued a safety alert warning health care professionals and patients to avoid the use of hydroxychloroquine and chloroquine outside of hospital or clinical trial settings due to potential increased risk for serious heart-related adverse events and death.
The drugs, which can be used to treat hospitalized patients with COVID-19, may lead to adverse events including ventricular tachycardia, QT interval prolongation, ventricular fibrillation and death in some cases, according to a MedWatch alert from the FDA.
Comments from President Trump on hydroxychloroquine and chloroquine for the treatment of COVID-19 have led to a surge in the demand for these drugs despite the lack of clinical trial results. The agency recently authorized the temporary use of hydroxychloroquine and chloroquine for the treatment of hospitalized patients with COVID-19 through an emergency use authorization despite the drugs’ having several adverse effects including life-threatening arrhythmias. The FDA is reviewing the safety of the drugs’ use outside hospital and clinical trial settings, according to the alert.
According to the alert, case reports have documented heart-related problems, particularly arrhythmias, in patients taking hydroxychloroquine or chloroquine alone or combined with azithromycin or other QT-prolonging medications. Earlier this month, the American Heart Association, the American College of Cardiology and the Heart Rhythm Society issued a guidance on the use of hydroxychloroquine and azithromycin, recommending against their concomitant use in patients with baseline congenital long QT syndrome or a QT of at least 500 milliseconds and encouraging any patients prescribed both to have their cardiac rhythm and QT interval monitored.
The FDA alert noted that hydroxychloroquine and chloroquine should be used with caution in patients with known heart and kidney disease, as they may be at elevated risk for the cardiac adverse effects.
The FDA recommended that patients currently taking hydroxychloroquine and chloroquine for the treatment of autoimmune conditions or malaria should continue taking them as prescribed, as the benefits outweigh the risks at recommended doses. These patients should not stop taking them without consulting their health care provider, according to the alert.
“Be aware that there are no proven treatments for COVID-19 and no vaccine,” the FDA stated in the alert. “If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness or fainting, seek medical attention right away by calling 911.”
The alert also instructed consumers not to buy these medicines from online pharmacies without a prescription. Consumers are also instructed not to take hydroxychloroquine or chloroquine if it has not been prescribed to them by a health care provider, as death and serious poisoning have been reported with chloroquine products that are not intended for human consumption.
The FDA recommended health professionals evaluate and monitor their patients who are taking hydroxychloroquine and chloroquine as per the emergency use authorization. Several items that should be monitored include electrolytes, ECG, hepatic tests and renal function.
Hydroxychloroquine and chloroquine have been FDA approved for the treatment or prevention of malaria. In addition, hydroxychloroquine has been approved by the FDA to treat patients with autoimmune conditions including systemic lupus erythematosus in adults, chronic discoid lupus erythematosus and rheumatoid arthritis.