April 24, 2020

Citing safety concerns, the U.S. FDA has advised that the drugs hydroxychloroquine and chloroquine should not be used to treat COVID-19 outside of clinical trials or hospital settings. Both medications can cause serious heart rhythm problems.

Hydroxychloroquine and chloroquine are FDA-approved to treat malaria and certain autoimmune disorders. Although they are being explored as potential treatments for COVID-19, neither drug is approved for use in COVID-19 patients. However, they are available to COVID-19 patients through clinical trials, an FDA-issued Emergency Use Authorization, and certain state regulations under specific guidelines.

The primary danger that concerns the FDA at this time stems from known side effects of the drugs and reports of serious heart rhythm problems in COVID-19 patients who have been treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines. QT prolongation, a known potential side effect of these medications, is a type of electrical disturbance that causes the heart to take longer to recharge than normal between beats. This can contribute to serious and potentially life-threatening complications such as tachycardia (rapid heartbeat). Certain patients are at higher risk of these adverse effects, including patients who have other health issues such as heart and kidney disease.

For this reason, the FDA advises that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, should only be used to treat COVID-19 in clinical trials or hospital settings. Patients taking these medications for FDA-approved indications should continue taking them as prescribed. Patients should not stop these medications without first talking to their healthcare provider. Anyone who is taking hydroxychloroquine or chloroquine and experiences irregular heartbeats, dizziness, or fainting should seek medical attention immediately by calling 911.

The FDA is reminding the public that there are no proven treatments for COVID-19. The medications cited in this safety warning should not be purchased from online pharmacies without a prescription from a healthcare professional. Consumers should not take any form of chloroquine that has not been prescribed for them by a healthcare professional. There have been instances of serious poisoning and death after use of a chloroquine product not intended to be taken by humans.

If consumers have these medicines in their homes, they should keep them in childproof containers and out of reach of children. Healthcare professionals are encouraged to consider enrolling patients in clinical trials if considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19. In addition, patients and healthcare professionals are asked to report any issues that may be related to taking these medications to the FDA’s MedWatch program.

The full safety communication can be found on the FDA’s website.

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