Adverse Drug Events: Hydroxychloroquine and Heart Rhythm

April 14, 2020

The FDA has issued a Drug Safety Communication (DSC) that cautions against the use of hydroxychloroquine or chloroquine for COVID-19 treatment outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems.

Hydroxychloroquine and chloroquine can cause serious heart problems, especially in people with health issues such as heart or kidney disease. The risk increases when used in combination with other medications.

A review of the FDA Adverse Event Reporting System Database, published medical literature, and the National Poison Data System has led to concerns regarding serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events were reported from the hospital and outpatient settings for treating or preventing COVID-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death.

If used for inpatient treatment of COVID-19 as described in the March 28, 2020 FDA Emergency Use Authorization, clinicians should obtain and monitor ECG, electrolytes, renal function, and hepatic tests.

The complete Drug Safety Communication can be viewed on the FDA website Exit Disclaimer: You Are Leaving www.ihs.gov .

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.