FDA Drug Safety Communication re: Hydroxychloroquine / Chloroquine

April 24, 2020

The Food and Drug Administration (FDA) released a safety communication regarding the use of hydroxychloroquine/chloroquine due to its pro-arrhythmia potential. It is important to remember these drugs have been authorized by FDA temporarily through an Emergency Use Authorization (UAE,) meaning that these drugs can be used in patients with COVID-19, but they are not approved for COVID-19 treatment since they have not been shown to be safe or effective against COVID-19 infection. Since these medications can prolong the QT interval, the initial evaluation should include reviewing whether the patient is on any other QT prolonging drugs including azithromycin and reviewing the patient's baseline QT interval. The FDA has reviewed recent adverse event reports including ventricular arrhythmias in patients being treated with hydroxychlorochine/chloroquine for COVID-19, both alone and in combination with azithromycin or other QT prolonging drugs. The FDA recommends enrolling these patients in a clinical trial when at all possible and performing ongoing cardiac monitoring of these patients.

The HRS Health Policy group will continue to post FDA updates that are EP-related and useful for EP clinicians.

Read Full FDA Drug Safety Communication